Trial of Hypofractionated Radiation Therapy for Glioblastoma

NCT02206230 | Completed Phase 2 DMC

• 1 other identifier: BR-02-1401
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioblastoma

Keywords

glioblastoma; radiotherapy; hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  defined as the time between randomization and death due to any cause.

  Patients without an event will be censored the last time they were known to be alive. Median, 6-month, 1-year, and 2-year OS rates will be measured.

Secondary Outcomes (3)

• Progression-free survival (PFS)

  Patients without an event will be censored at date of last follow-up for progression. Patients with no post-baseline follow-up for progression will be censored at day of randomization. Median, 6-month, 1-yr, and 2-yr PFS rates will be measured

• Adverse events according to NCI CTCAE version 4.0 criteria.

  Evaluated weekly during radiation therapy; on C1D1 and at the end of every 2 cycles of adjuvant temozolomide; post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative

• Health-related quality-of-life as assessed by MMSE and EORTC QLQ-C30/QLQ-BN20 questionnaires.

  Evaluated at baseline, weekly during radiation therapy, at the end of every 2 cycles of adjuvant temozolomide, and post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative

Study Arms (2)

Hypofractionated radiation therapy

EXPERIMENTAL

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)..

Radiation: Hypofractionated radiation therapy

Standard radiation therapy

ACTIVE COMPARATOR

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)..

Radiation: Standard radiation therapy

Interventions

Hypofractionated radiation therapy RADIATION

Hypofractionated radiation therapy

Standard radiation therapy RADIATION

Standard radiation therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Related Publications (1)

• 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.

  PMID: 36273738 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Samir Patel, MD

  Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1, randomized, open label

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: August 1, 2014
• Study Start: September 25, 2014
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CA (1)