NRG-BN001

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.

• Histologically proven diagnosis of glioblastoma (WHO grade IV) confirmed by central review prior to step 2 registration
•     Diagnosis must be made by surgical excision, either partial or complete. Stereotactic biopsy and cavitronic ultrasonic surgical (CUSA) techniques are not allowed
• Age ≥ 18
• Karnofsky performance status ≥ 70 within 28 days
• Tumor tissue that is determined by central pathology review
• History/physical examination within 28 days
• The patient must have recovered from effects of surgery, postoperative infection, and other complications within 28 days
• Documentation of steroid doses within 28 days
    

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years
• Recurrent or multifocal malignant gliomas
• Any site of distant disease
• Prior chemotherapy or radiosensitizers for cancers of the head and neck region
• Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
• Prior radiotherapy to the head or neck

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.