Back to resultsProton/Photon Rt - Benign Meningiomas(P92-13)
Primary Purpose
Benign Meningioma
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Standard Treatment
Higher Dose
Sponsored by
About this trial
This is an interventional treatment trial for Benign Meningioma focused on measuring sphenoid region, parasellar area, photon radiation therapy, proton radiation therapy
Eligibility Criteria
Inclusion Criteria:
- Age 18 or over
- Histological documentation of benign meningioma
- Documentation by imaging studies (CT and/ or MRI) or residual or recurrent intracranial tumor
- Karnofsky performance status of ≥ 70
- Study specific informed consent
Exclusion Criteria:
- Malignant meningiomas
- Prior cranial irradiation, except treatment of localized skin cancer of the face or scalp
- Patients having a concurrent primary cancer (except skin)
- Patients having another cancer controlled < 3 years
- Pregnant patients
Sites / Locations
- Massachusetts General Hosital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard Treatment
Higher Dose Treatment
Arm Description
Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Outcomes
Primary Outcome Measures
Progression Free Survival
The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.
Secondary Outcome Measures
Acute Toxicities
The number of participants that experienced the specified acute toxicities (any grade) as assessed by Radiation Therapy Oncology Acute Morbidity Scoring Criteria. Acute toxicities were assessed from the start of treatment through day 90 of treatment.
Late Toxicities
The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.
Local Failure Rate
The number of participants with local failure. Local failure is defined as radiologic progression seen on follow-up scans showing tumor margin(s) extending in any direction at least five mm beyond that seen on baseline scans.
Full Information
NCT ID
NCT02947984
First Posted
December 28, 2007
Last Updated
May 15, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02947984
Brief Title
Proton/Photon Rt - Benign Meningiomas(P92-13)
Official Title
Prospective Study Of Patients With Recurrent Or Incomplete Excised Benign Intercranial Meningiomas For The Evaluation Of Treatment Result With Combined Proton And Photon Irradiation To Doses 55.8 Or 63.0 CGE
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the best radiation dose for participants with meningioma that has grown back after previous surgery, or which the surgeon has been unable to remove completely. This research study is designed to determine whether a higher dose of radiation will decrease the likelihood that the tumor will grow back, compared to the probability of re-growth that occurs after standard radiation doses.
Detailed Description
After initial interview and physical examination, an immobilization device (head mask, neck support, back support, etc.) will be made for the participant. A treatment planning CT will be performed and a radiation treatment plan will be based on this CT scan.
The radiation dose will usually be given once a day, five days per week. The radiation treatment will take between 7 and 8 1/2 weeks, including treatment planning.
Treatment doses will vary, and the dose each participant will receive will be made on the basis of random assignment. Participants will either receive the usual dose of 55.8 CGE in 31 treatments or 1.8 CGE, or 63 CGE in 35 treatments of 1.8 CGE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Meningioma
Keywords
sphenoid region, parasellar area, photon radiation therapy, proton radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Treatment
Arm Type
Experimental
Arm Description
Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Arm Title
Higher Dose Treatment
Arm Type
Experimental
Arm Description
63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Intervention Type
Radiation
Intervention Name(s)
Standard Treatment
Intervention Description
55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Intervention Type
Radiation
Intervention Name(s)
Higher Dose
Intervention Description
55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.
Time Frame
5, 10, 15 years
Secondary Outcome Measure Information:
Title
Acute Toxicities
Description
The number of participants that experienced the specified acute toxicities (any grade) as assessed by Radiation Therapy Oncology Acute Morbidity Scoring Criteria. Acute toxicities were assessed from the start of treatment through day 90 of treatment.
Time Frame
90 Days
Title
Late Toxicities
Description
The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.
Time Frame
5 Years
Title
Local Failure Rate
Description
The number of participants with local failure. Local failure is defined as radiologic progression seen on follow-up scans showing tumor margin(s) extending in any direction at least five mm beyond that seen on baseline scans.
Time Frame
15 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or over
Histological documentation of benign meningioma
Documentation by imaging studies (CT and/ or MRI) or residual or recurrent intracranial tumor
Karnofsky performance status of ≥ 70
Study specific informed consent
Exclusion Criteria:
Malignant meningiomas
Prior cranial irradiation, except treatment of localized skin cancer of the face or scalp
Patients having a concurrent primary cancer (except skin)
Patients having another cancer controlled < 3 years
Pregnant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen A Shih, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hosital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proton/Photon Rt - Benign Meningiomas(P92-13)
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