Proton/Photon Rt - Benign Meningiomas(P92-13)

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Standard Treatment	Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Higher Dose Treatment	Higher Dose	63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	5, 10, 15 years	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

Name	Time	Method
Acute Toxicities	90 Days	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	5 Years	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	15 Years	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.