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S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma

Primary Purpose

Lymphoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
R-CHOP regimen
laboratory biomarker analysis
fludeoxyglucose F 18
selective external radiation therapy
yttrium Y 90 ibritumomab tiuxetan
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)

    • Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group
    • Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections
    • Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible

  • Patients must have non-bulky stage I or II disease by Ann Arbor classification

    • This staging excludes FDG-PET evaluation
    • Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible

  • Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration

    • Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol
    • If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable

  • Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma

    • Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration

  • Patients may have either measurable or evaluable limited-stage DLBCL

    • Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible
    • If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187)
    • All measurable disease must be assessed within 28 days prior to registration
    • Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
  • Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)
  • Patients must not be pregnant or nursing
  • Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period
  • Patients must not be known to be HIV-positive

  • No other prior malignancy is allowed except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission
    • Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

Sites / Locations

  • Providence Cancer Center
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Aurora Presbyterian Hospital
  • Boulder Community Hospital
  • Penrose Cancer Center at Penrose Hospital
  • St. Anthony Central Hospital
  • Kaiser Permanente - Denver
  • Porter Adventist Hospital
  • Presbyterian - St. Luke's Medical Center
  • St. Joseph Hospital
  • Rose Medical Center
  • CCOP - Colorado Cancer Research Program
  • Swedish Medical Center
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  • North Colorado Medical Center
  • Kaiser Permanente - Lafayette
  • Littleton Adventist Hospital
  • Sky Ridge Medical Center
  • Hope Cancer Care Center at Longmont United Hospital
  • McKee Medical Center
  • Parker Adventist Hospital
  • St. Mary - Corwin Regional Medical Center
  • North Suburban Medical Center
  • Exempla Lutheran Medical Center
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  • Yale Cancer Center
  • Piedmont Hospital
  • Northside Hospital Cancer Center
  • Saint Joseph's Hospital of Atlanta
  • CCOP - Atlanta Regional
  • WellStar Cobb Hospital
  • John B. Amos Cancer Center
  • Charles B. Eberhart Cancer Center at DeKalb Medical Center
  • Piedmont Fayette Hospital
  • Gwinnett Medical Center
  • Kennestone Cancer Center at Wellstar Kennestone Hospital
  • Southern Regional Medical Center
  • Harbin Clinic Cancer Center - Medical Oncology
  • Kapiolani Medical Center at Pali Momi
  • Oncare Hawaii, Incorporated - Pali Momi
  • Leeward Radiation Oncology
  • Cancer Research Center of Hawaii
  • OnCare Hawaii, Incorporated - Lusitana
  • Queen's Cancer Institute at Queen's Medical Center
  • Straub Clinic and Hospital, Incorporated
  • OnCare Hawaii, Incorporated - Kuakini
  • Hawaii Medical Center - East
  • Kuakini Medical Center
  • Kapiolani Medical Center for Women and Children
  • Castle Medical Center
  • Kauai Medical Clinic
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  • Mountain States Tumor Institute at St. Luke's Regional Medical Center
  • Illinois CancerCare - Bloomington
  • St. Joseph Medical Center
  • Graham Hospital
  • Illinois CancerCare - Canton
  • Illinois CancerCare - Carthage
  • Memorial Hospital
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Hematology and Oncology Associates
  • Eureka Community Hospital
  • Illinois CancerCare - Eureka
  • Galesburg Clinic, PC
  • Illinois CancerCare - Galesburg
  • Illinois CancerCare - Havana
  • Kellogg Cancer Care Center
  • Provena St. Mary's Regional Cancer Center - Kankakee
  • Illinois CancerCare - Kewanee Clinic
  • North Shore Oncology and Hematology Associates, Limited - Libertyville
  • Illinois CancerCare - Macomb
  • McDonough District Hospital
  • Illinois CancerCare - Monmouth
  • OSF Holy Family Medical Center
  • Cancer Care and Hematology Specialists of Chicagoland - Niles
  • BroMenn Regional Medical Center
  • Community Cancer Center
  • Illinois CancerCare - Community Cancer Center
  • Community Hospital of Ottawa
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
  • Cancer Treatment Center at Pekin Hospital
  • Illinois CancerCare - Pekin
  • Proctor Hospital
  • CCOP - Illinois Oncology Research Association
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
  • Methodist Medical Center of Illinois
  • OSF St. Francis Medical Center
  • Illinois CancerCare - Peru
  • Illinois Valley Community Hospital
  • Illinois CancerCare - Princeton
  • Perry Memorial Hospital
  • Hematology Oncology Associates - Skokie
  • Illinois CancerCare - Spring Valley
  • St. Francis Hospital and Health Centers - Beech Grove Campus
  • Reid Hospital & Health Care Services
  • Siouxland Hematology-Oncology Associates, LLP
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Cancer Center of Kansas, PA - Chanute
  • Cancer Center of Kansas, PA - Dodge City
  • Cancer Center of Kansas, PA - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas, PA - Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas, PA - Liberal
  • Cancer Center of Kansas, PA - McPherson
  • Cancer Center of Kansas, PA - Newton
  • Menorah Medical Center
  • Saint Luke's Hospital - South
  • Cancer Center of Kansas, PA - Parsons
  • CCOP - Kansas City
  • Cancer Center of Kansas, PA - Pratt
  • Cancer Center of Kansas, PA - Salina
  • Cancer Center of Kansas, PA - Wellington
  • Associates in Womens Health, PA - North Review
  • Cancer Center of Kansas, PA - Medical Arts Tower
  • Cancer Center of Kansas, PA - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas, PA - Winfield
  • Lucille P. Markey Cancer Center at University of Kentucky
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Genesys Regional Medical Center
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Foote Memorial Hospital
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Sparrow Regional Cancer Center
  • St. Mary Mercy Hospital
  • St. Joseph Mercy Oakland
  • Mercy Regional Cancer Center at Mercy Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • St. John Macomb Hospital
  • Fairview Ridges Hospital
  • Mercy and Unity Cancer Center at Mercy Hospital
  • Duluth Clinic Cancer Center - Duluth
  • CCOP - Duluth
  • Miller - Dwan Medical Center
  • Fairview Southdale Hospital
  • Mercy and Unity Cancer Center at Unity Hospital
  • Hutchinson Area Health Care
  • HealthEast Cancer Care at St. John's Hospital
  • Minnesota Oncology - Maplewood
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  • Hennepin County Medical Center - Minneapolis
  • New Ulm Medical Center
  • Humphrey Cancer Center at North Memorial Outpatient Center
  • CCOP - Metro-Minnesota
  • Park Nicollet Cancer Center
  • Regions Hospital Cancer Care Center
  • United Hospital
  • St. Francis Cancer Center at St. Francis Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Willmar Cancer Center at Rice Memorial Hospital
  • Minnesota Oncology - Woodbury
  • Saint Luke's Cancer Institute at Saint Luke's Hospital
  • North Kansas City Hospital
  • Heartland Hematology Oncology Associates, Incorporated
  • Research Medical Center
  • Saint Luke's East - Lee's Summit
  • Parvin Radiation Oncology
  • Heartland Regional Medical Center
  • Saint Joseph Oncology, Incorporated
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • CCOP - Montana Cancer Consortium
  • St. Vincent Healthcare Cancer Care Services
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Billings Clinic - Downtown
  • Bozeman Deaconess Cancer Center
  • St. James Healthcare Cancer Care
  • Great Falls Clinic - Main Facility
  • Sletten Cancer Institute at Benefis Healthcare
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology at KRMC
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Wayne Memorial Hospital, Incorporated
  • Rex Cancer Center at Rex Hospital
  • Iredell Memorial Hospital
  • MeritCare Broadway
  • CCOP - MeritCare Hospital
  • Roger Maris Cancer Center at MeritCare Hospital
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • CCOP - Dayton
  • Blanchard Valley Medical Associates
  • Middletown Regional Hospital
  • Wayne Hospital
  • Charles F. Kettering Memorial Hospital
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • Geisinger Cancer Institute at Geisinger Health
  • Cancer Centers of the Carolinas - Faris Road
  • Cancer Centers of the Carolinas - Grove Commons
  • Greenville Hospital Cancer Center
  • CCOP - Greenville
  • Cancer Centers of the Carolinas - Greer Medical Oncology
  • Cancer Centers of the Carolinas - Seneca
  • CCOP - Upstate Carolina
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • Cancer Centers of the Carolinas - Spartanburg
  • Sanford Cancer Center at Sanford USD Medical Center
  • University of Texas Health Science Center at San Antonio
  • Cancer Therapy and Research Center
  • University Hospital - San Antonio
  • Island Hospital Cancer Care Center at Island Hospital
  • St. Joseph Cancer Center
  • Olympic Hematology and Oncology
  • Highline Medical Center Cancer Center
  • Columbia Basin Hematology
  • Skagit Valley Hospital Cancer Care Center
  • Harrison Poulsbo Hematology and Onocology
  • Harborview Medical Center
  • Minor and James Medical, PLLC
  • Fred Hutchinson Cancer Research Center
  • Group Health Central Hospital
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • Polyclinic First Hill
  • University Cancer Center at University of Washington Medical Center
  • North Puget Oncology at United General Hospital
  • Cancer Care Northwest - Spokane South
  • Evergreen Hematology and Oncology, PS
  • Wenatchee Valley Medical Center
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
  • Gundersen Lutheran Center for Cancer and Blood
  • Rocky Mountain Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PET Negative: R-CHOP

PET Positive: IFRT +Zevalin

Arm Description

R-CHOP x 3 Cycles

Standard IFRT+ Zevalin IV per ABW

Outcomes

Primary Outcome Measures

Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion >1.5 cm in the longest axis.

Secondary Outcome Measures

Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival
Formalin-fixed, paraffin-embedded tissue from the diagnostic biopsy is collected and used to determine germinal center B-cell (GCB) phenotype. GCB subtype of DLBCL is defined by gene-expression profiling that is performed using quantitative nuclease protection assay (qNPA).

Full Information

First Posted
May 21, 2011
Last Updated
July 7, 2023
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01359592
Brief Title
S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
Official Title
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 3, 2020 (Actual)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.
Detailed Description
OBJECTIVES: Primary To assess the 5-year progression-free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission tomography (PET)/CT scan to direct therapy after 3 courses of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP). Secondary To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients with newly diagnosed limited-stage DLBCL. To evaluate toxicity of the protocol treatments in this patient population. To evaluate the response probability in this patient population. To evaluate overall survival in the overall population, and within the PET+ and PET- subgroups. To estimate the rate of upstaging at baseline by PET/CT at baseline among patients newly diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in patients upstaged by PET/CT at baseline to advanced DLBCL. To describe outcomes in the subgroup of patients upstaged by PET/CT. To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs stromal-2 gene expression signatures with PFS or overall survival. OUTLINE: This is a multicenter study. Patients are stratified according to whether the patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT (yes vs no). Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally on days 1-5. Treatment repeats every 21 days for 3* courses. NOTE: *Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP. FDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of course 3. Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks. Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9. Patients may undergo blood sample collection at baseline for correlative studies. Bone marrow tissue samples may be also collected for correlative studies. After completion of study therapy, patients are followed up every 6 months for 2 years and then yearly for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET Negative: R-CHOP
Arm Type
Active Comparator
Arm Description
R-CHOP x 3 Cycles
Arm Title
PET Positive: IFRT +Zevalin
Arm Type
Experimental
Arm Description
Standard IFRT+ Zevalin IV per ABW
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Other
Intervention Name(s)
R-CHOP regimen
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Type
Radiation
Intervention Name(s)
selective external radiation therapy
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 ibritumomab tiuxetan
Primary Outcome Measure Information:
Title
Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
Description
Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion >1.5 cm in the longest axis.
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Description
Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.
Time Frame
up to 5 years
Title
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Description
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time Frame
up to 4 months or time of disease progression.
Title
Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Description
Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame
up to 5 years
Title
Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP
Description
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time Frame
Up to 4 months
Title
Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival
Description
Formalin-fixed, paraffin-embedded tissue from the diagnostic biopsy is collected and used to determine germinal center B-cell (GCB) phenotype. GCB subtype of DLBCL is defined by gene-expression profiling that is performed using quantitative nuclease protection assay (qNPA).
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL) Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible Patients must have non-bulky stage I or II disease by Ann Arbor classification This staging excludes FDG-PET evaluation Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration Patients may have either measurable or evaluable limited-stage DLBCL Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187) All measurable disease must be assessed within 28 days prior to registration Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration PATIENT CHARACTERISTICS: Zubrod performance status 0-2 Absolute neutrophil count (ANC) ≥ 1,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome) Patients must not be pregnant or nursing Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period Patients must not be known to be HIV-positive No other prior malignancy is allowed except for the following: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer from which the patient is currently in complete remission Any other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel O. Persky, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Cancer Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Aurora Presbyterian Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-9019
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
St. Anthony Central Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Kaiser Permanente - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Kaiser Permanente - Lafayette
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hope Cancer Care Center at Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
St. Mary - Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northside Hospital Cancer Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1611
Country
United States
Facility Name
Saint Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1701
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
WellStar Cobb Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Charles B. Eberhart Cancer Center at DeKalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Piedmont Fayette Hospital
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Kennestone Cancer Center at Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Southern Regional Medical Center
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274-2600
Country
United States
Facility Name
Harbin Clinic Cancer Center - Medical Oncology
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Kapiolani Medical Center at Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Oncare Hawaii, Incorporated - Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Leeward Radiation Oncology
City
'Ewa Beach
State/Province
Hawaii
ZIP/Postal Code
96706
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Lusitana
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Institute at Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital, Incorporated
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817-3169
Country
United States
Facility Name
Hawaii Medical Center - East
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kuakini Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Castle Medical Center
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96734
Country
United States
Facility Name
Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Illinois CancerCare - Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
St. Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare - Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare - Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Hematology and Oncology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare - Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Clinic, PC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare - Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare - Havana
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Kellogg Cancer Care Center
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Provena St. Mary's Regional Cancer Center - Kankakee
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Facility Name
Illinois CancerCare - Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
North Shore Oncology and Hematology Associates, Limited - Libertyville
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Illinois CancerCare - Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Illinois CancerCare - Monmouth
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
OSF Holy Family Medical Center
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
Cancer Care and Hematology Specialists of Chicagoland - Niles
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare - Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Illinois CancerCare - Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois CancerCare - Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare - Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Hematology Oncology Associates - Skokie
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Illinois CancerCare - Spring Valley
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
St. Francis Hospital and Health Centers - Beech Grove Campus
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Reid Hospital & Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51102
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, PA - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas, PA - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Cancer Center of Kansas, PA - Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas, PA - McPherson
City
McPherson
State/Province
Kansas
ZIP/Postal Code
67460
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Saint Luke's Hospital - South
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
CCOP - Kansas City
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Duluth Clinic Cancer Center - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805-1983
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller - Dwan Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
HealthEast Cancer Care at St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Minnesota Oncology - Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Facility Name
Humphrey Cancer Center at North Memorial Outpatient Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Cancer Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
St. Francis Cancer Center at St. Francis Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Willmar Cancer Center at Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology - Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Saint Luke's Cancer Institute at Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
North Kansas City Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Heartland Hematology Oncology Associates, Incorporated
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Saint Luke's East - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Parvin Radiation Oncology
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Joseph Oncology, Incorporated
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare Cancer Care Services
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Healthcare Cancer Care
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Great Falls Clinic - Main Facility
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology at KRMC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Rex Cancer Center at Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Iredell Memorial Hospital
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
MeritCare Broadway
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Roger Maris Cancer Center at MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Cancer Centers of the Carolinas - Faris Road
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Cancer Centers of the Carolinas - Grove Commons
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Hospital Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Cancer Centers of the Carolinas - Greer Medical Oncology
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Cancer Centers of the Carolinas - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Cancer Centers of the Carolinas - Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Hospital - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Island Hospital Cancer Care Center at Island Hospital
City
Anacortes
State/Province
Washington
ZIP/Postal Code
98221
Country
United States
Facility Name
St. Joseph Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Highline Medical Center Cancer Center
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Columbia Basin Hematology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Skagit Valley Hospital Cancer Care Center
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Harrison Poulsbo Hematology and Onocology
City
Poulsbo
State/Province
Washington
ZIP/Postal Code
98370
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Minor and James Medical, PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
Polyclinic First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
North Puget Oncology at United General Hospital
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Evergreen Hematology and Oncology, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801-2028
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Gundersen Lutheran Center for Cancer and Blood
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States

12. IPD Sharing Statement

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S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma

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