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Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

Primary Purpose

Grade II Meningioma, Intracranial Meningioma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clinical Observation
Radiation Therapy
Sponsored by
NRG Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Grade II Meningioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION:
  • The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution; WHO grade will be assigned according to WHO 2016 criteria
  • Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor; GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings
  • Step 1 registration must occur within 180 days of the initial surgery; within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, step 1 registration must occur within 180 days of the initial resection
  • For step 1 registration the operating neurosurgeon must provide the modified Simpson grade
  • GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients; if a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained; all sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection; these same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery; computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study
  • NOTE: Central pathology review must occur between steps 1 and 2 of registration; once appropriate pathology specimens are received, central pathology review will occur within 15 days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization
  • PRIOR TO STEP 2 REGISTRATION:
  • Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration
  • History/physical examination, including neurologic examination within 60 days prior to step 2 registration
  • Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration
  • If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception

Exclusion Criteria:

  • Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
  • Definitive evidence of metastatic meningioma
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)
  • Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas

  • Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to:

    • Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration
    • Transmural myocardial infarction within the last 6 months prior to step 2 registration
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
    • Type II neurofibromatosis (NF2)
    • Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count < 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 2 registration
    • Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, etc) or receive gadolinium; note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia
  • Pregnancy and/or nursing females

Sites / Locations

  • University of Alabama at Birmingham Cancer Center
  • Saint Joseph's Hospital and Medical CenterRecruiting
  • Mayo Clinic Hospital in Arizona
  • Mayo Clinic in Arizona
  • University of Arizona Cancer Center-Orange Grove CampusRecruiting
  • Banner University Medical Center - TucsonRecruiting
  • University of Arizona Cancer Center-North CampusRecruiting
  • Kaiser Permanente-AnaheimRecruiting
  • Sutter Cancer Centers Radiation Oncology Services-AuburnRecruiting
  • Kaiser Permanente DublinRecruiting
  • Kaiser Permanente Los Angeles Medical CenterRecruiting
  • Los Angeles County-USC Medical CenterRecruiting
  • USC / Norris Comprehensive Cancer CenterRecruiting
  • Memorial Medical CenterRecruiting
  • Kaiser Permanente Oakland-BroadwayRecruiting
  • Kaiser Permanente-OntarioRecruiting
  • UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
  • Stanford Cancer Institute Palo Alto
  • Kaiser Permanente-Rancho Cordova Cancer CenterRecruiting
  • Rohnert Park Cancer CenterRecruiting
  • Sutter Cancer Centers Radiation Oncology Services-RosevilleRecruiting
  • The Permanente Medical Group-Roseville Radiation OncologyRecruiting
  • Sutter Medical Center SacramentoRecruiting
  • South Sacramento Cancer CenterRecruiting
  • Kaiser Permanente Medical Center - Santa ClaraRecruiting
  • Kaiser Permanente Cancer Treatment CenterRecruiting
  • Sutter Solano Medical Center/Cancer CenterRecruiting
  • Hartford HospitalRecruiting
  • Yale UniversityRecruiting
  • Helen F Graham Cancer Center
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • TidalHealth Nanticoke / Allen Cancer Center
  • Boca Raton Regional Hospital
  • UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
  • UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
  • Baptist MD Anderson Cancer CenterRecruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
  • Miami Cancer Institute
  • AdventHealth OrlandoRecruiting
  • AdventHealth East Orlando
  • Moffitt Cancer CenterRecruiting
  • Grady Health SystemRecruiting
  • Emory Proton Therapy CenterRecruiting
  • Piedmont HospitalRecruiting
  • Emory University Hospital/Winship Cancer InstituteRecruiting
  • Emory Saint Joseph's HospitalRecruiting
  • Northside Hospital
  • Northside Hospital-Forsyth
  • Piedmont Fayette HospitalRecruiting
  • Piedmont Newnan HospitalRecruiting
  • Piedmont Henry HospitalRecruiting
  • Queen's Medical CenterRecruiting
  • The Cancer Center of Hawaii-LilihaRecruiting
  • Northwestern UniversityRecruiting
  • Rush University Medical CenterRecruiting
  • University of IllinoisRecruiting
  • Decatur Memorial Hospital
  • NorthShore University HealthSystem-Evanston HospitalRecruiting
  • Northwestern Medicine Cancer Center DelnorRecruiting
  • NorthShore University HealthSystem-Glenbrook HospitalRecruiting
  • NorthShore University HealthSystem-Highland Park HospitalRecruiting
  • Loyola University Medical CenterRecruiting
  • Northwestern Medicine Cancer Center WarrenvilleRecruiting
  • Indiana University/Melvin and Bren Simon Cancer Center
  • IU Health Methodist Hospital
  • Iowa Methodist Medical Center
  • University of Iowa/Holden Comprehensive Cancer Center
  • University of Kansas Cancer CenterRecruiting
  • University of Kansas Cancer Center-Overland ParkRecruiting
  • University of Kentucky/Markey Cancer Center
  • LSU Health Sciences Center at ShreveportRecruiting
  • MaineHealth Coastal Cancer Treatment CenterRecruiting
  • Maine Medical Center-Bramhall CampusRecruiting
  • MaineHealth Cancer Care Center of York CountyRecruiting
  • Maine Medical Center- Scarborough CampusRecruiting
  • Maryland Proton Treatment Center
  • University of Maryland/Greenebaum Cancer Center
  • Tufts Medical CenterRecruiting
  • Saint Joseph Mercy Hospital
  • University of Michigan Comprehensive Cancer Center
  • Saint Joseph Mercy Chelsea
  • Henry Ford Macomb Hospital-Clinton TownshipRecruiting
  • Henry Ford HospitalRecruiting
  • Ascension Saint John Hospital
  • Trinity Health Saint Mary Mercy Livonia Hospital
  • Ascension Saint Mary's HospitalRecruiting
  • Saint John Macomb-Oakland Hospital
  • Henry Ford West Bloomfield HospitalRecruiting
  • Essentia Health Cancer CenterRecruiting
  • Miller-Dwan HospitalRecruiting
  • Mayo Clinic in Rochester
  • Park Nicollet Clinic - Saint Louis ParkRecruiting
  • Regions HospitalRecruiting
  • University of Mississippi Medical Center
  • MU Health - University Hospital/Ellis Fischel Cancer CenterRecruiting
  • Siteman Cancer Center at West County HospitalRecruiting
  • Washington University School of MedicineRecruiting
  • Siteman Cancer Center-South CountyRecruiting
  • Siteman Cancer Center at Saint Peters HospitalRecruiting
  • Benefis Healthcare- Sletten Cancer InstituteRecruiting
  • Kalispell Regional Medical CenterRecruiting
  • University of Nebraska Medical Center
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Rutgers New Jersey Medical School
  • Capital Health Medical Center-HopewellRecruiting
  • ProCure Proton Therapy Center-Somerset
  • Robert Wood Johnson University Hospital Somerset
  • University of New Mexico Cancer CenterRecruiting
  • New York-Presbyterian/Brooklyn Methodist HospitalRecruiting
  • Memorial Sloan Kettering Commack
  • The New York Hospital Medical Center of Queens
  • Memorial Sloan Kettering Westchester
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • NYP/Weill Cornell Medical Center
  • University of Rochester
  • Memorial Sloan Kettering Nassau
  • Westchester Medical CenterRecruiting
  • UNC Lineberger Comprehensive Cancer Center
  • Case Western Reserve UniversityRecruiting
  • Cleveland Clinic FoundationRecruiting
  • Ohio State University Comprehensive Cancer CenterRecruiting
  • Mercy Cancer Center-Elyria
  • UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
  • ProMedica Flower HospitalRecruiting
  • UHHS-Westlake Medical CenterRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Legacy Mount Hood Medical Center
  • Legacy Good Samaritan Hospital and Medical Center
  • Saint Luke's University Hospital-Bethlehem Campus
  • Christiana Care Health System-Concord Health Center
  • Geisinger Medical CenterRecruiting
  • Geisinger Medical Oncology-LewisburgRecruiting
  • Lewistown HospitalRecruiting
  • Thomas Jefferson University Hospital
  • Fox Chase Cancer Center
  • Temple University HospitalRecruiting
  • Geisinger Cancer Services-PottsvilleRecruiting
  • Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
  • Lankenau Medical Center
  • Prisma Health Cancer Institute - Spartanburg
  • Medical University of South Carolina
  • Prisma Health Cancer Institute - Faris
  • Prisma Health Cancer Institute - Eastside
  • Prisma Health Cancer Institute - Greer
  • Prisma Health Cancer Institute - Seneca
  • Vanderbilt University/Ingram Cancer Center
  • UT Southwestern/Simmons Cancer Center-DallasRecruiting
  • M D Anderson Cancer CenterRecruiting
  • University of Texas Health Science Center at San Antonio
  • American Fork Hospital / Huntsman Intermountain Cancer CenterRecruiting
  • Logan Regional HospitalRecruiting
  • Intermountain Medical CenterRecruiting
  • McKay-Dee Hospital CenterRecruiting
  • Utah Valley Regional Medical CenterRecruiting
  • Riverton HospitalRecruiting
  • LDS HospitalRecruiting
  • Norris Cotton Cancer Center-NorthRecruiting
  • Virginia Commonwealth University/Massey Cancer Center
  • University of Washington Medical Center - MontlakeRecruiting
  • Legacy Salmon Creek Hospital
  • Langlade Hospital and Cancer CenterRecruiting
  • Marshfield Medical Center-EC Cancer CenterRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting
  • Marshfield Medical Center-MarshfieldRecruiting
  • Froedtert Menomonee Falls HospitalRecruiting
  • Medical College of WisconsinRecruiting
  • Marshfield Clinic-Minocqua CenterRecruiting
  • Marshfield Medical Center-Rice LakeRecruiting
  • Ascension Saint Michael's HospitalRecruiting
  • Marshfield Medical Center-River Region at Stevens PointRecruiting
  • Aspirus Regional Cancer CenterRecruiting
  • Diagnostic and Treatment CenterRecruiting
  • Aspirus Cancer Care - Wisconsin RapidsRecruiting
  • Tom Baker Cancer Centre
  • Cross Cancer InstituteRecruiting
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • London Regional Cancer Program
  • University Health Network-Princess Margaret HospitalRecruiting
  • CHUM - Centre Hospitalier de l'Universite de MontrealRecruiting
  • The Research Institute of the McGill University Health Centre (MUHC)Recruiting
  • Allan Blair Cancer Centre
  • Tata Memorial HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Iwate Medical University HospitalRecruiting
  • Kyorin University HospitalRecruiting
  • Keio UniversityRecruiting
  • Hiroshima University Hospital
  • Saitama Medical University International Medical Center
  • National Cancer Center HospitalRecruiting
  • King Faisal Specialist Hospital and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Arm I (Clinical Observation)

Arm II (Radiation Therapy)

Arm Description

Patients undergo observation after gross total resection.

Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions after gross total resection.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
Kaplan-Meier method will be used to calculate the PFS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in PFS between the two arms (Peto 1972).

Secondary Outcome Measures

Overall Survival (OS)
Kaplan-Meier method will be used to calculate the OS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in OS between the two arms (Peto 1972). Cox proportional hazard model will be used to determine the adjusted treatment effect on OS, with patient pretreatment characteristics as covariates.
5 Year Overall Survival (OS)
Will be calculated based on the Kaplan-Meier curve.
Disease-Specific Survival (DSS)
Will be calculated using the cumulative incidence function for each arm. The HR for the treatment effect on DSS will be calculated using Gray's method under the competing risk approach, with death due to non-disease related cause treated as the competing risk (Gray 1988). Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates (Fine 1999).
3 Year Disease-Specific Survival (DSS)
Will be calculated using the cumulative incidence function for each arm.
5 Year Disease-Specific Survival (DSS)
Will be calculated using the cumulative incidence function for each arm.
3 Year Progression-Free Survival (PFS)
Will be calculated based on the Kaplan-Meier curve.
5 Year Progression-Free Survival (PFS)
Will be calculated based on the Kaplan-Meier curve.
Neurocognitive Function (NCF)
Longitudinal analysis will be performed to compare NCF over time between the 2 arms, using the NCF Clinical Trial Battery (CTB) composite score. Early change from baseline in CTB composite score will be evaluated and compared between the 2 arms using 2-sample t tests.
Patient Reported Outcomes (PRO) as assessed by MDASI-BT
Longitudinal analysis will be performed to compare symptom burden over time between the 2 arms, using the MDASI-BT. Early change from baseline in symptom burden will be evaluated and compared between the 2 arms using 2-sample t tests.
Assessment of pHH3 mitotic index
The Kaplan-Meier method will be used to estimate the PFS and OS rates by pHH3 category. The HRs on the effect of pHH3 on PFS and OS, respectively will be calculated using the Cox proportional hazard model and will be tested using the log-rank test. Multivariate analyses will be conducted with patient pretreatment characteristics, such as age and Simpson resection grade, included as covariates.
Incidence of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4 (exclusive of alopecia)
The number of adverse events will be measured using the CTCAE, version 4

Full Information

First Posted
June 6, 2017
Last Updated
September 18, 2023
Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03180268
Brief Title
Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
Official Title
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
June 15, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Detailed Description
PRIMARY OBJECTIVES: I. To determine, in terms of progression-free survival (PFS), the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma. SECONDARY OBJECTIVES: I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Outcomes and patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution pathology. VIII. Tissue microarray construction, and assessment of pHH3 mitotic index and molecular correlates to OS. OUTLINE: Patients are randomized to 1 of 2 arms after undergoing gross total resection. ARM I: Patients undergo observation. ARM II: Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each). After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grade II Meningioma, Intracranial Meningioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Clinical Observation)
Arm Type
Other
Arm Description
Patients undergo observation after gross total resection.
Arm Title
Arm II (Radiation Therapy)
Arm Type
Experimental
Arm Description
Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions after gross total resection.
Intervention Type
Other
Intervention Name(s)
Clinical Observation
Intervention Description
Undergo observation
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RADIATION, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Kaplan-Meier method will be used to calculate the PFS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in PFS between the two arms (Peto 1972).
Time Frame
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Kaplan-Meier method will be used to calculate the OS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in OS between the two arms (Peto 1972). Cox proportional hazard model will be used to determine the adjusted treatment effect on OS, with patient pretreatment characteristics as covariates.
Time Frame
From randomization to death due to any cause, assessed up to 10 years
Title
5 Year Overall Survival (OS)
Description
Will be calculated based on the Kaplan-Meier curve.
Time Frame
At 5 years after randomization
Title
Disease-Specific Survival (DSS)
Description
Will be calculated using the cumulative incidence function for each arm. The HR for the treatment effect on DSS will be calculated using Gray's method under the competing risk approach, with death due to non-disease related cause treated as the competing risk (Gray 1988). Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates (Fine 1999).
Time Frame
From randomization to disease-related death, assessed up to 10 years
Title
3 Year Disease-Specific Survival (DSS)
Description
Will be calculated using the cumulative incidence function for each arm.
Time Frame
At 3 years after randomization
Title
5 Year Disease-Specific Survival (DSS)
Description
Will be calculated using the cumulative incidence function for each arm.
Time Frame
At 5 years after randomization
Title
3 Year Progression-Free Survival (PFS)
Description
Will be calculated based on the Kaplan-Meier curve.
Time Frame
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years after randomization.
Title
5 Year Progression-Free Survival (PFS)
Description
Will be calculated based on the Kaplan-Meier curve.
Time Frame
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years after randomization.
Title
Neurocognitive Function (NCF)
Description
Longitudinal analysis will be performed to compare NCF over time between the 2 arms, using the NCF Clinical Trial Battery (CTB) composite score. Early change from baseline in CTB composite score will be evaluated and compared between the 2 arms using 2-sample t tests.
Time Frame
Baseline up to 60 months after randomization
Title
Patient Reported Outcomes (PRO) as assessed by MDASI-BT
Description
Longitudinal analysis will be performed to compare symptom burden over time between the 2 arms, using the MDASI-BT. Early change from baseline in symptom burden will be evaluated and compared between the 2 arms using 2-sample t tests.
Time Frame
Baseline up to 60 months after randomization
Title
Assessment of pHH3 mitotic index
Description
The Kaplan-Meier method will be used to estimate the PFS and OS rates by pHH3 category. The HRs on the effect of pHH3 on PFS and OS, respectively will be calculated using the Cox proportional hazard model and will be tested using the log-rank test. Multivariate analyses will be conducted with patient pretreatment characteristics, such as age and Simpson resection grade, included as covariates.
Time Frame
Up to 10 years after randomization
Title
Incidence of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4 (exclusive of alopecia)
Description
The number of adverse events will be measured using the CTCAE, version 4
Time Frame
Up to 3 years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PRIOR TO STEP 1 REGISTRATION: The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution; WHO grade will be assigned according to WHO 2016 criteria Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor; GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings Step 1 registration must occur within 180 days of the initial surgery; within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, step 1 registration must occur within 180 days of the initial resection For step 1 registration the operating neurosurgeon must provide the modified Simpson grade GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients; if a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained; all sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection; these same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery; computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis The patient or a legally authorized representative must provide study-specific informed consent prior to study entry If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study NOTE: Central pathology review must occur between steps 1 and 2 of registration; once appropriate pathology specimens are received, central pathology review will occur within 15 days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization PRIOR TO STEP 2 REGISTRATION: Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration History/physical examination, including neurologic examination within 60 days prior to step 2 registration Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception Exclusion Criteria: Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma Definitive evidence of metastatic meningioma Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible) Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to: Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration Transmural myocardial infarction within the last 6 months prior to step 2 registration Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration Type II neurofibromatosis (NF2) Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count < 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 2 registration Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, etc) or receive gadolinium; note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia Pregnancy and/or nursing females
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
C. Leland Rogers, MD
Phone
602-406-6761
Email
leland.rogers@dignityhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Leland Rogers, MD
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-602-4111
First Name & Middle Initial & Last Name & Degree
Igor J. Barani
Facility Name
Mayo Clinic Hospital in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Arizona Cancer Center-Orange Grove Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
520-694-8900
First Name & Middle Initial & Last Name & Degree
Baldassarre Stea
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Baldassarre Stea
Facility Name
University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Baldassarre Stea
Facility Name
Kaiser Permanente-Anaheim
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-398-3996
Email
clinical.trials@kp.org
First Name & Middle Initial & Last Name & Degree
Michael R. Girvigian
Facility Name
Sutter Cancer Centers Radiation Oncology Services-Auburn
City
Auburn
State/Province
California
ZIP/Postal Code
95603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
Melanie.Cook@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Christopher U. Jones
Facility Name
Kaiser Permanente Dublin
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
First Name & Middle Initial & Last Name & Degree
Samantha A. Seaward
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-398-3996
Email
clinical.trials@kp.org
First Name & Middle Initial & Last Name & Degree
Michael R. Girvigian
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
323-865-0451
First Name & Middle Initial & Last Name & Degree
Eric L. Chang
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
323-865-0451
First Name & Middle Initial & Last Name & Degree
Eric L. Chang
Facility Name
Memorial Medical Center
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
Melanie.Cook@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Christopher U. Jones
Facility Name
Kaiser Permanente Oakland-Broadway
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Samantha A. Seaward
Facility Name
Kaiser Permanente-Ontario
City
Ontario
State/Province
California
ZIP/Postal Code
91761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-398-3996
Email
clinical.trials@kp.org
First Name & Middle Initial & Last Name & Degree
Michael R. Girvigian
Facility Name
UC Irvine Health/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-827-8839
Email
ucstudy@uci.edu
First Name & Middle Initial & Last Name & Degree
Xiao-Tang Kong
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente-Rancho Cordova Cancer Center
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Samantha A. Seaward
Facility Name
Rohnert Park Cancer Center
City
Rohnert Park
State/Province
California
ZIP/Postal Code
94928
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Samantha A. Seaward
Facility Name
Sutter Cancer Centers Radiation Oncology Services-Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
Melanie.Cook@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Christopher U. Jones
Facility Name
The Permanente Medical Group-Roseville Radiation Oncology
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Samantha A. Seaward
Facility Name
Sutter Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
Melanie.Cook@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Christopher U. Jones
Facility Name
South Sacramento Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Samantha A. Seaward
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Samantha A. Seaward
Facility Name
Kaiser Permanente Cancer Treatment Center
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Samantha A. Seaward
Facility Name
Sutter Solano Medical Center/Cancer Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
Melanie.Cook@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Christopher U. Jones
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
860-545-5363
First Name & Middle Initial & Last Name & Degree
Alexis M. Demopoulos
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Nicholas A. Blondin
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
TidalHealth Nanticoke / Allen Cancer Center
City
Seaford
State/Province
Delaware
ZIP/Postal Code
19973
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UM Sylvester Comprehensive Cancer Center at Coral Gables
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Eric A. Mellon
Facility Name
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Eric A. Mellon
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
904-202-7468
First Name & Middle Initial & Last Name & Degree
Michael R. Olson
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Eric A. Mellon
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
407-303-2090
Email
FH.Cancer.Research@flhosp.org
First Name & Middle Initial & Last Name & Degree
Sherif Makar
Facility Name
AdventHealth East Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Individual Site Status
Suspended
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-679-0775
Email
ClinicalTrials@moffitt.org
First Name & Middle Initial & Last Name & Degree
Hsiang-Hsuan M. Yu
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-489-9164
First Name & Middle Initial & Last Name & Degree
Bree R. Eaton
Facility Name
Emory Proton Therapy Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-251-2854
Email
allyson.anderson@emory.edu
First Name & Middle Initial & Last Name & Degree
Bree R. Eaton
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-425-7943
Email
ORS@piedmont.org
First Name & Middle Initial & Last Name & Degree
Adam W. Nowlan
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-778-1868
First Name & Middle Initial & Last Name & Degree
Bree R. Eaton
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-851-7115
First Name & Middle Initial & Last Name & Degree
Bree R. Eaton
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northside Hospital-Forsyth
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Piedmont Fayette Hospital
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Adam W. Nowlan
Facility Name
Piedmont Newnan Hospital
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
ors@piedmont.org
First Name & Middle Initial & Last Name & Degree
Adam W. Nowlan
Facility Name
Piedmont Henry Hospital
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-425-1800
First Name & Middle Initial & Last Name & Degree
Adam W. Nowlan
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-545-8548
First Name & Middle Initial & Last Name & Degree
Richard Y. Lee
Facility Name
The Cancer Center of Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-547-6881
First Name & Middle Initial & Last Name & Degree
Richard Y. Lee
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-695-1301
Email
cancer@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Sean Sachdev
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-942-5498
Email
clinical_trials@rush.edu
First Name & Middle Initial & Last Name & Degree
Ken Tatebe
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-355-3046
First Name & Middle Initial & Last Name & Degree
Matthew Koshy
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NorthShore University HealthSystem-Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
847-570-2109
First Name & Middle Initial & Last Name & Degree
Bruce E. Brockstein
Facility Name
Northwestern Medicine Cancer Center Delnor
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Vinai Gondi
Facility Name
NorthShore University HealthSystem-Glenbrook Hospital
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
847-570-2109
First Name & Middle Initial & Last Name & Degree
Bruce E. Brockstein
Facility Name
NorthShore University HealthSystem-Highland Park Hospital
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
847-570-2109
First Name & Middle Initial & Last Name & Degree
Bruce E. Brockstein
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
708-226-4357
First Name & Middle Initial & Last Name & Degree
Anupama Chundury
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Vinai Gondi
Facility Name
Indiana University/Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Fen Wang
Facility Name
University of Kansas Cancer Center-Overland Park
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Fen Wang
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
LSU Health Sciences Center at Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
318-813-1404
Email
LPost@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Gary V. Burton
Facility Name
MaineHealth Coastal Cancer Treatment Center
City
Bath
State/Province
Maine
ZIP/Postal Code
04530
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Maine Medical Center-Bramhall Campus
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-885-7565
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
MaineHealth Cancer Care Center of York County
City
Sanford
State/Province
Maine
ZIP/Postal Code
04073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-459-1600
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Maine Medical Center- Scarborough Campus
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-396-8090
Email
wrighd@mmc.org
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Maryland Proton Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
617-636-5000
Email
ContactUsCancerCenter@TuftsMedicalCenter.org
First Name & Middle Initial & Last Name & Degree
John E. Mignano
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Suspended
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Suspended
Facility Name
Henry Ford Macomb Hospital-Clinton Township
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-916-3721
Email
CTOResearch@hfhs.org
First Name & Middle Initial & Last Name & Degree
Eleanor M. Walker
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-916-3721
Email
CTOResearch@hfhs.org
First Name & Middle Initial & Last Name & Degree
Eleanor M. Walker
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Suspended
Facility Name
Trinity Health Saint Mary Mercy Livonia Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Individual Site Status
Suspended
Facility Name
Ascension Saint Mary's Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
989-907-8411
Email
lori.srebinski@ascension.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Individual Site Status
Suspended
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-916-3721
Email
CTOResearch@hfhs.org
First Name & Middle Initial & Last Name & Degree
Eleanor M. Walker
Facility Name
Essentia Health Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
218-786-3308
Email
CancerTrials@EssentiaHealth.org
First Name & Middle Initial & Last Name & Degree
Bret E. Friday
Facility Name
Miller-Dwan Hospital
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
218-786-3308
Email
CancerTrials@EssentiaHealth.org
First Name & Middle Initial & Last Name & Degree
Bret E. Friday
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MU Health - University Hospital/Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
573-882-7440
First Name & Middle Initial & Last Name & Degree
Gregory B. Biedermann
Facility Name
Siteman Cancer Center at West County Hospital
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Jiayi Huang
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Jiayi Huang
Facility Name
Siteman Cancer Center-South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Jiayi Huang
Facility Name
Siteman Cancer Center at Saint Peters Hospital
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Jiayi Huang
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-639-6918
Email
cancer.research.nurse@dartmouth.edu
First Name & Middle Initial & Last Name & Degree
Alan C. Hartford
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
732-235-7356
First Name & Middle Initial & Last Name & Degree
Bruce G. Haffty
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Individual Site Status
Suspended
Facility Name
Capital Health Medical Center-Hopewell
City
Pennington
State/Province
New Jersey
ZIP/Postal Code
08534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
609-394-4130
Email
clinicaltrials@capitalhealth.org
First Name & Middle Initial & Last Name & Degree
Navid Redjal
Facility Name
ProCure Proton Therapy Center-Somerset
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Robert Wood Johnson University Hospital Somerset
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
505-925-0348
Email
HSC-ClinicalTrialInfo@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Benny J. Liem
Facility Name
New York-Presbyterian/Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
718-780-3677
Email
Adg9003@nyp.org
First Name & Middle Initial & Last Name & Degree
Hani L. Ashamalla
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The New York Hospital Medical Center of Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NYP/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Suspended
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Keith Meritz
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Prashant Vempati
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-223-8100
Email
TaussigResearch@ccf.org
First Name & Middle Initial & Last Name & Degree
John H. Suh
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-293-5066
Email
Jamesline@osumc.edu
First Name & Middle Initial & Last Name & Degree
Joshua D. Palmer
Facility Name
Mercy Cancer Center-Elyria
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Individual Site Status
Suspended
Facility Name
UH Seidman Cancer Center at Lake Health Mentor Campus
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Prashant Vempati
Facility Name
ProMedica Flower Hospital
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
419-824-1842
Email
PCIOncResearch@promedica.org
First Name & Middle Initial & Last Name & Degree
Steven J. Rubin
Facility Name
UHHS-Westlake Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Prashant Vempati
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
J. S. Thompson
Facility Name
Legacy Mount Hood Medical Center
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Legacy Good Samaritan Hospital and Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Luke's University Hospital-Bethlehem Campus
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Christiana Care Health System-Concord Health Center
City
Chadds Ford
State/Province
Pennsylvania
ZIP/Postal Code
19317
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-271-5251
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Heath B. Mackley
Facility Name
Geisinger Medical Oncology-Lewisburg
City
Lewisburg
State/Province
Pennsylvania
ZIP/Postal Code
17837
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-374-8555
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Heath B. Mackley
Facility Name
Lewistown Hospital
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-242-7703
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Heath B. Mackley
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
215-728-2983
First Name & Middle Initial & Last Name & Degree
Curtis T. Miyamoto
Facility Name
Geisinger Cancer Services-Pottsville
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-275-6401
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Heath B. Mackley
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-271-5251
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Heath B. Mackley
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Suspended
Facility Name
Prisma Health Cancer Institute - Spartanburg
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Individual Site Status
Suspended
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Suspended
Facility Name
Prisma Health Cancer Institute - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Suspended
Facility Name
Prisma Health Cancer Institute - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Suspended
Facility Name
Prisma Health Cancer Institute - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Individual Site Status
Suspended
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
214-648-7097
Email
canceranswerline@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Zabi Wardak
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Debra N. Yeboa
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
American Fork Hospital / Huntsman Intermountain Cancer Center
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
801-855-4100
Email
officeofresearch@imail.org
First Name & Middle Initial & Last Name & Degree
Grant K. Hunter
Facility Name
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
435-716-6400
Email
officeofresearch@imail.org
First Name & Middle Initial & Last Name & Degree
Grant K. Hunter
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
801-507-3950
Email
officeofresearch@imail.org
First Name & Middle Initial & Last Name & Degree
Grant K. Hunter
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
801-387-7426
Email
officeofresearch@imail.org
First Name & Middle Initial & Last Name & Degree
Grant K. Hunter
Facility Name
Utah Valley Regional Medical Center
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
801-357-7965
Email
officeofresearch@imail.org
First Name & Middle Initial & Last Name & Degree
Grant K. Hunter
Facility Name
Riverton Hospital
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
801-507-3950
Email
officeofresearch@imail.org
First Name & Middle Initial & Last Name & Degree
Grant K. Hunter
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
801-408-1347
Email
officeofresearch@imail.org
First Name & Middle Initial & Last Name & Degree
Grant K. Hunter
Facility Name
Norris Cotton Cancer Center-North
City
Saint Johnsbury
State/Province
Vermont
ZIP/Postal Code
05819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-639-6918
Email
cancer.research.nurse@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Alan C. Hartford
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-804-8824
First Name & Middle Initial & Last Name & Degree
Lia M. Halasz
Facility Name
Legacy Salmon Creek Hospital
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Langlade Hospital and Cancer Center
City
Antigo
State/Province
Wisconsin
ZIP/Postal Code
54409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-623-9869
Email
Juli.Alford@aspirus.org
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Benjamin E. Lawler
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-622-8922
First Name & Middle Initial & Last Name & Degree
Steven P. Howard
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Benjamin E. Lawler
Facility Name
Froedtert Menomonee Falls Hospital
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
262-257-5100
First Name & Middle Initial & Last Name & Degree
Jennifer M. Connelly
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
414-805-3666
First Name & Middle Initial & Last Name & Degree
Jennifer M. Connelly
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Benjamin E. Lawler
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Benjamin E. Lawler
Facility Name
Ascension Saint Michael's Hospital
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-847-2353
Email
Beth.Knetter@aspirus.org
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
Marshfield Medical Center-River Region at Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Benjamin E. Lawler
Facility Name
Aspirus Regional Cancer Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-405-6866
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
Diagnostic and Treatment Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-799-3989
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Benjamin E. Lawler
Facility Name
Aspirus Cancer Care - Wisconsin Rapids
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-422-7718
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Suspended
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
780-432-8500
First Name & Middle Initial & Last Name & Degree
Samir I. Patel
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Individual Site Status
Suspended
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Individual Site Status
Suspended
Facility Name
University Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
416-946-4501
Email
clinical.trials@uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Derek S. Tsang
Facility Name
CHUM - Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
514-890-8000
Ext
12725
Email
info.cr.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Jean-Paul Bahary
Facility Name
The Research Institute of the McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
514-934-1934
Ext
48354
Email
evelyn.ortega@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Bassam S. Abdulkarim
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Tata Memorial Hospital
City
Mumbai
ZIP/Postal Code
400 012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Tejpal Gupta
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
hassi@med.hokudai.ac.jp
First Name & Middle Initial & Last Name & Degree
Shigeru Yamaguchi
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
81-19-613-7111
First Name & Middle Initial & Last Name & Degree
Takaaki Beppu
Facility Name
Kyorin University Hospital
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Motoo Nagane
Facility Name
Keio University
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
03 5363-3848
First Name & Middle Initial & Last Name & Degree
Masahiro Toda
Facility Name
Hiroshima University Hospital
City
Hiroshima City
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Suspended
Facility Name
Saitama Medical University International Medical Center
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Suspended
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104 0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
81-3-3542-2511
Email
www-admin@ncc.go.jp
First Name & Middle Initial & Last Name & Degree
Yoshitaka Narita
Facility Name
King Faisal Specialist Hospital and Research Centre
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
Individual Site Status
Suspended

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

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