Status:
ACTIVE_NOT_RECRUITING
Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma
Lead Sponsor:
John Flickinger
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 fractio...
Detailed Description
All patients in the study will receive usual care with short-course radiotherapy (RT) and TMZ-chemo pills. There are three phases of treatment in this study: the Chemo-radiation Phase, the Adjuvant P...
Eligibility Criteria
Inclusion
- 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, ANC \> or equal 1500, Platelet count greater or equal 100. Liver function tests and creatinine not greater than twice ULN.
- 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 (KPS) below 60 or ECOG of 3 or 4
- 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
- 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.
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04019262
Start Date
December 14 2021
End Date
July 1 2027
Last Update
June 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center, Radiation Oncology
Pittsburgh, Pennsylvania, United States, 15232