30
Participants
Start Date
April 1, 2020
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
Neoadjuvant chemoradiation
Intensity modulation radiation therapy (IMRT) with a simultaneous integrated boost with Fixed-gantry IMRT, helical tomotherapy, or Vesicular Modulated Arc Therapy (VMAT) can be used. All photon treatments shall be delivered with megavoltage machines of a minimum energy of 6 Megavolt (MV) photons. Selection of the appropriate photon energy(ies) should be based on optimizing the radiation dose distribution within the target volume and minimizing dose to non-target normal tissue.
Drug Therapy with Temozolomide (benzolamide) (Standard of Care)
During Concomitant Radiation Therapy on the same day as the first fraction of radiotherapy. 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 for a maximum of 49 days. The drug will be administered orally daily during radiotherapy, as best tolerated by the patient. During weekends without radiotherapy (Saturday and Sunday), the drug will be taken in the morning. The dose will be determined using actual body surface area (BSA) as calculated in square meters at the beginning of the concomitant treatment. The BSA will be calculated from the height obtained at the pretreatment visit. Capsules of temozolomide are available in 5, 20, 100, 140, 180, and 250 mg. The daily dose will be rounded to the nearest 5 mg.
Surgery post Radiation and Temozolomide (benzolamide)
Surgical resection of GBM will be done after radiation and Temozolomide treatment.
Geisinger Medical Center, Danville
Geisinger Wyoming Valley Medical Center, Wilkes-Barre
Lead Sponsor
Geisinger Clinic
OTHER