Chemo-Radiation for Glioblastoma
Trial Summary
What is the purpose of this trial?
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.
Research Team
John Flickinger, MD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
Adults diagnosed with WHO Grade IV Glioblastoma who can consent, have acceptable liver and kidney function tests, normal blood counts, are not pregnant or breastfeeding, and do not have distant cancer spread. Prior chemotherapy is allowed but no prior radiotherapy to the brain. Participants must be able to follow the study plan as assessed by the investigator.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Chemo-radiation
Patients receive either 40 Gy in 15 fractions or 25 Gy in 5 fractions with concurrent temozolomide
Adjuvant
Standard monthly 5-day cycles of TMZ-chemo at 150 mg/m^2 per day for up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Radiation Therapy
- Temozolomide
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
John Flickinger
Lead Sponsor