A Phase II Randomized Trial of Proton Vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients With IDH Mutant, Low to Intermediate Grade Gliomas
This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.
• Prior to STEP 1 REGISTRATION
• Tumor tissue must be available for submission for central pathology review
• Documentation from the enrolling site confirming the presence of IDH mutation and 1p/19q status; the provided information must document assays performed in clinical laboratory improvement amendments (CLIA)-approved laboratories
• Only English speaking patients are eligible to participate as the cognitive and quality of life assessments are available only in English
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
• Karnofsky performance status of >= 70 within 30 days prior to registration
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
• Platelets >= 100,000 cells/mm^3
• Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)
• Bilirubin =< 1.5 upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
• BUN < 30 mg/dl
• Serum creatinine < 1.5 mg/dl
• Post-operative magnetic resonance (MR) imaging with contrast is mandatory obtained for radiation therapy planning; enrolling sites are highly encouraged to obtain thin-slice (<1.5 mm) 3D T1 pre and post contrast and Axial T2/FLAIR sequences for planning purposes
• Prior to STEP 2 REGISTRATION
• The following baseline neurocognitive assessments must be completed and uploaded prior to step 2 registration: HVLT-R, TMT Parts A and B, and COWA
• Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire. These quality of life forms will be required and data entered at step 2 registration.
• Financial clearance for proton therapy treatment prior to step 2 registration
• Centrally reviewed histologically proven diagnosis of supratentorial, Word Health Organization (WHO) grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma, with IDH mutation