Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma (STRONG)
Glioblastoma, Malignant Glioma, Brain Tumors
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, High-grade Glioma, Brain Tums, Temozolomide, Stem cell radiation therapy, IMRT, Proton beam radiotherapy, Conventional external beam radiotherapy, Quality of Life, Neurocognition
Eligibility Criteria
Inclusion Criteria:
- Patients with newly diagnosed with high grade glioma (grade 3 or 4) having completed surgery.
- Patients must be ≥ 18 and ≤ 70 years of age;
- WHO/ECOG Performance Status of 2 or less.
- MRI of the brain as delineated above.
- Patients must sign a study-specific informed consent prior to study entry.
Exclusion Criteria:
- Evidence of brainstem involvement on radiographs;
- Evidence of oligodendroglioma histology.
- Evidence of progressive disease at the time of study entry;
- Evidence of extracranial distant metastatic disease;
- Prior cranial irradiation;
- Patients may not be entered on other studies that have progression free, disease free, or overall survival as a primary endpoint;
- Patients with synchronous or prior malignancy, other than non-melanomatous skin cancer unless disease free greater than 3 years;
- Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus; patients with childbearing potential must practice appropriate contraception.
Sites / Locations
- Roosevelt Hospital
Arms of the Study
Arm 1
Experimental
Stem Cell Radiotherapy and Temozolomide
One treatment of 2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy over 6 weeks. Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality. Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays).