Status:
COMPLETED
Trial of Hypofractionated Radiation Therapy for Glioblastoma
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Cross Cancer Institute
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma
Detailed Description
Hypofractionated radiation therapy (RT) in the treatment of patients with glioblastoma, 18 - 70 years of age with good performance status (ECOG 0 - 2), will be well tolerated and yield survival non-in...
Eligibility Criteria
Inclusion
- Newly-diagnosed, histologically proven, intracranial glioblastoma or gliosarcoma treated with maximal safe resection, which may be biopsy alone if resection is not possible.
- History and physical examination, including neurological examination, within 14 days prior to randomization.
- Age between 18 and 70 years, inclusive.
- ECOG performance score 0-2.
- Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization (Stupp et al.).
- Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below: (Stupp et al.)
- ANC ≥ 1.5 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L
- Serum creatinine ≤ 1.5 times ULN
- Total serum bilirubin ≤ 1.5 times ULN
- ALT \< 3 times ULN
- AST \< 3 times ULN
- Alkaline phosphatase \< 3 times ULN
- Patients must sign a study-specific informed consent prior to study registration and must be willing to comply with study treatment, questionnaire completion and follow-up.
Exclusion
- Recurrent or multifocal malignant gliomas. Multicentric gliomas, defined as multiple, discrete areas of enhancement on T1 weighted MRI sequences with contrast all contained within one connected region of abnormality on T2 weighted/FLAIR MRI sequences, are allowed to enroll on this study.
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless expected survival from prior malignancy is ≥ 5 years.
- Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide
- Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study registration
- Any severe, active co-morbidity precluding delivery of temozolomide.
- Women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to temozolomide.
Key Trial Info
Start Date :
September 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT02206230
Start Date
September 25 2014
End Date
February 14 2023
Last Update
January 31 2024
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2