Neoadjuvant Chemoradiation for Resectable Glioblastoma

PHASE2SuspendedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 1, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
GlioblastomaSurgeryHigh Grade Glioma
Interventions
RADIATION

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

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.

PROCEDURE

Surgery post Radiation and Temozolomide (benzolamide)

Surgical resection of GBM will be done after radiation and Temozolomide treatment.

Trial Locations (2)

17822

Geisinger Medical Center, Danville

18711

Geisinger Wyoming Valley Medical Center, Wilkes-Barre

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Geisinger Clinic

OTHER

NCT04209790 - Neoadjuvant Chemoradiation for Resectable Glioblastoma | Biotech Hunter | Biotech Hunter