Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma
Glioblastoma
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Chemo-Radiation Therapy, temozolomide, lymphocytopenia
Eligibility 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, 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 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.
Sites / Locations
- University of Pittsburgh Medical Center, Radiation OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
40 Gy in 15 fractions
25 Gy in 5 fractions
Patients randomized to 40 Gy in 15 fractions will receive 75 mg/m^2 temozolomide per day for 15 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m^2 for upto 1 year.
Patients randomized to 25 Gy in 5 fractions will receive 150 mg/m^2 temozolomide per day for 5 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m^2 for upto 1 year.