Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (NCT02179086)
🩺 Plain-English Summary (8th-Grade Level)
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (36 items) and avoid the listed exclusions (26 items).
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Recurrent or multifocal malignant gliomas
- Any site of distant disease (for example, drop metastases from the GBM tumor site)
- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide)
- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
- Severe, active co-morbidity, defined as follows:
- Unstable angina at step 2 registration
- Transmural myocardial infarction within the last 6 months prior to step 2 registration
- Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \>= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to step 2 registration (Note: EKG to be performed only if clinical suspicion of cardiac issue)
- New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (237 Sites)
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Saint Joseph's Hospital and Medical Center — Phoenix, Arizona
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona
- Arizona Oncology Associates-West Orange Grove — Tucson, Arizona
- Banner University Medical Center - Tucson — Tucson, Arizona
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
- AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California
- Eden Hospital Medical Center — Castro Valley, California
- Fresno Cancer Center — Fresno, California
- Marin General Hospital — Greenbrae, California
- Loma Linda University Medical Center — Loma Linda, California
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Cedars Sinai Medical Center — Los Angeles, California
- Fremont - Rideout Cancer Center — Marysville, California
- Memorial Medical Center — Modesto, California
- Kaiser Permanente Oakland-Broadway — Oakland, California
- Saint Joseph Hospital - Orange — Orange, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- Palo Alto Medical Foundation Health Care — Palo Alto, California
- Pomona Valley Hospital Medical Center — Pomona, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.