Trial of Hypofractionated Radiation Therapy for Glioblastoma

NCT ID: NCT02206230

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-25
• Study Completion Date: 2023-02-14

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-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.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated radiation therapy

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)..

Group Type: EXPERIMENTAL

Hypofractionated radiation therapy

Intervention Type: RADIATION

Standard radiation therapy

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)..

Group Type: ACTIVE_COMPARATOR

Standard radiation therapy

Intervention Type: RADIATION

Interventions

Hypofractionated radiation therapy

Intervention Type: RADIATION

Standard radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cross Cancer Institute

OTHER

Sponsor Role: collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samir Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Cross Cancer Institute

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

References

Yang F, Dinakaran D, Heikal AA, Yaghoobpour Tari S, Ghosh S, Amanie J, Murtha A, Rowe LS, Roa WH, Patel S. Dosimetric predictors of toxicity in a randomized study of short-course vs conventional radiotherapy for glioblastoma. Radiother Oncol. 2022 Dec;177:152-157. doi: 10.1016/j.radonc.2022.10.016. Epub 2022 Oct 20.

Reference Type: DERIVED

PMID: 36273738 (View on PubMed)

Other Identifiers

BR-02-1401

Identifier Type: -

Identifier Source: org_study_id