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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Benign Meningioma

Intervention / Treatment
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* Radiation: Standard Treatment
* Radiation: Higher Dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Treatment<br>Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. | Radiation: Standard Treatment<br>* 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.<br>|
| Experimental: Higher Dose Treatment<br>63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week. | Radiation: Higher Dose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5, 10, 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 Days | 
| Late Toxicities | The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale. | 5 Years | 
| 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. | 15 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sphenoid region, parasellar area, photon radiation therapy, proton radiation therapy