Trial of Hypofractionated Radiation Therapy for Glioblastoma

AHS Cancer Control Alberta

Status and phase: Completed; Phase 2

Conditions: Glioblastoma

Treatments: Radiation: Standard radiation therapy; Radiation: Hypofractionated radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02206230

BR-02-1401

Details and patient eligibility

About

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

Full 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-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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Newly-diagnosed, histologically proven, intracranial glioblastoma or gliosarcoma treated with maximal safe resection, which may be biopsy alone if resection is not possible.

2. History and physical examination, including neurological examination, within 14 days prior to randomization.

3. Age between 18 and 70 years, inclusive.

4. ECOG performance score 0-2.

5. Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization (Stupp et al.).

6. Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below: (Stupp et al.)

   1. ANC ≥ 1.5 x 10^9/L
   2. Platelets ≥ 100 x 10^9/L
   3. Serum creatinine ≤ 1.5 times ULN
   4. Total serum bilirubin ≤ 1.5 times ULN
   5. ALT < 3 times ULN
   6. AST < 3 times ULN
   7. Alkaline phosphatase < 3 times ULN

7. 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 criteria

1. 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.

2. Prior invasive malignancy (except for non-melanomatous skin cancer) unless expected survival from prior malignancy is ≥ 5 years.

3. Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide

4. Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study.

5. Severe, active co-morbidity, defined as follows:

   1. Unstable angina and/or congestive heart failure requiring hospitalization
   2. Transmural myocardial infarction within the last 6 months
   3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study registration
   4. Any severe, active co-morbidity precluding delivery of temozolomide.

6. Women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.

7. Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to temozolomide.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

Hypofractionated radiation therapy

Experimental group

Description:

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 6-12 cycles(as per institutional standard)..

Treatment:

Radiation: Hypofractionated radiation therapy

Standard radiation therapy

Active Comparator group

Description:

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 6-12 cycles(as per institutional standard)..

Treatment:

Radiation: Standard radiation therapy