Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma

• Status: Not yet recruiting
• Trial end date: 2028-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, open-label, exploratory trial of temozolomide-based chemo-radiotherapy which compares two widely used established radiation schedules with either 40 Gy in 15 fractions or 25 Gy in 5 fractions with concurrent temozolomide for both schedules in patients with glioblastoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Flickinger
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria for study enrollment:

• Age ≥18 with ability to provide written informed consent

• Pathologically confirmed WHO Grade IV Gliobastoma prior receiving radiotherapy

• Prior radiotherapy to a dose of ≥50Gy

• No signs of distant metastases

• Baseline laboratory assessment including CBC and blood chemistry

• Patient should not be pregnant. Urine or blood β-HCG within 14 days prior to study start for females who are not atleast one year post-menopausal or who have ot undergone a surgical sterilization procedure

• A baseline MRI scan of the brain is required to determine how much tumor is present for properly planning patient's radiotherapy.

• Karnofsky Performance Status ≥60 (ECOG 0-2)

• Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team).

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not eligible for enrollment:

• Evidence of distant metastases on any staging or imaging modality

• Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study)

• Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator.

• Karnofsky Performance Status less than 50

• Prior radiotherapy to involved site in brain.