Overview

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.