Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)

Summary

Participation Requirements

Description

Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group. If you are in Group 1, you will receive IMRT. If you are in Group 2, you will re...

Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group. If you are in Group 1, you will receive IMRT. If you are in Group 2, you will receive IMPT. Radiation Therapy: In both groups, you will receive radiation treatments each day, Monday-Friday, starting on Day 1. You will continue to receive radiation treatment until you have completed 30 total treatments. This is a total of up to 6 weeks of treatment. You will sign a separate consent form for the IMRT or IMPT that will explain the procedures and risks in detail. Study Visits: Before beginning radiation, you will have what is called a "simulation" to plan your radiation. During the simulation, you will be flat on your back on a computed tomography (CT) table and a soft plastic mask will be made to help hold your head still during treatment. This is the position you will be in when you receive radiation treatment. You will then have a CT scan, which will make computerized images to help plan your treatment. At Month 2 (+/- 30 days): You will have a physical exam, including measurement of your vital signs. You will have an MRI to check the status of the disease. You will be asked about any drugs you may be taking and side effects you may be having. You will complete the thinking skills tests and the questionnaires about your quality of life and symptoms. Length of Treatment: You may receive up to 6 weeks of radiation therapy. You will no longer be able to receive radiation therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your active participation on the study will be over after the follow-up visits. Follow-Up: At Month 4 (+/- 30 days) and then every 2 months for up to 2 years after radiation therapy: You will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may be having. You will have an MRI to check the status of the disease. You will complete the thinking skills tests and the questionnaires about your quality of life and symptoms. Starting 2 years after radiation therapy, the study staff will continue checking your medical record to find out about your health status from then on. This is an investigational study. IMRT is delivered using FDA-approved and commercially available methods. IMPT is investigational. Up to 90 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Tracking Information