Trial of Hypofractionated Radiation Therapy for Glioblastoma

Study Overview
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Brief Summary
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This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma

Detailed Description
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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-inferior to conventional fractioned RT, allowing significant abbreviation of the length of the radiation course required for these patients with limited survival. The importance of hypofractionation is, therefore, not in improving survival, but rather to shorten RT duration to improve patient comfort and convenience. This approach is pertinent given the limited life expectancy of glioblastoma and has been used in patients with prolonged survival including breast and prostate cancers.

Official Title
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A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma

Conditions
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Glioblastoma

Intervention / Treatment
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* Radiation: Hypofractionated radiation therapy
* Radiation: Standard radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed, histologically proven intracranial glioblastoma or gliosarcoma History and physical exam within 14 days prior to randomization Between 18 and 70 years of age ECOG 0 - 2 Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization Exclusion Criteria: Prior invasive malignancy unless disease free for > 3 years Prior head or neck RT (except for 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 Specific severe, active co-morbidities Not willing or able to use medically acceptable forms of contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated radiation therapy<br>Hypofractionated radiation therapy of 60 Gy in 20 fractions (3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles. | Radiation: Hypofractionated radiation therapy<br> <br> |
| Active Comparator: Standard radiation therapy<br>Standard radiation therapy of 60 Gy in 30 fractions (2 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles. | Radiation: Standard radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Patients without an event will be censored the last time they were known to be alive | Up to 24 months from date of randomization to date of death due to any cause | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Patients without an event will be assessed at the date of last follow-up for progression. Patients with no post-baseline follow-up for progression will be censored at the day of randomization. | Up to 24 month where PFS is defined as the time between randomization and radiographic progression based on RECIST criteria or death due to any cause. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypofractionated radiotherapy, glioblastoma, radiotherapy