A Prospective Trial of Neural Progenitor Cell Sparing Radiation Therapy Plus Temozolomide for Newly Diagnosed Glioblastoma Multiforme
Primary Objectives - To estimate the local recurrence (LR) rate at 1 year in the spared neural progenitor cell (NPC) containing niches of the brain in patients treated with NPC sparing radiation therapy (RT) plus temozolomide for newly diagnosed glioblastoma multiforme (GBM). Secondary Objectives - To quantify the extent of radiation dose sparing to the NPC containing regions that is possible without compromising tumor coverage in patients with newly diagnosed GBM - To examine the relationship between radiation dose to the NPC-containing niches and the proximity of the planning tumor volume to the NPC-containing regions. - To assess feasibility of evaluating cognitive function prospectively in patients undergoing NPC sparing RT for newly diagnosed GBM. - To explore if the potential change from baseline to six months in neurocognitive function as measured by the Mini Mental State Exam, Trail Making Test, Controlled Oral Word Association test (COWAT), Hopkins Verbal Learning Test-Revised, Digit Symbol Substitution Test is related to radiation dose to the NPC containing regions in patients treated with NPC sparing radiation for newly diagnosed GBM.
- Newly diagnosed, histologically confirmed glioblastoma multiforme. - Radiation and medical oncologist recommends adjuvant radiation plus temozolomide. - Must begin therapy within 6 weeks of biopsy or surgery. - No prior brain radiation. - Age greater than 18 years. - KPS greater than 60%. - Signed informed consent.
Patients will receive continuous daily temozolomide (75 mg per square meter of body surface area per day, 7 days per week from the first to the last day of radiation therapy), followed by 6 cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle). Patients will be treated to a total dose of 60 Gy with a once daily fractionation schedule of 2 Gy per fraction, administered five days per week.
05/21/2013 04:02 AM