Trial of Hypofractionated Radiation Therapy for Glioblastoma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02206230
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AHS Cancer Control Alberta
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Samir Patel, MD
Principal Investigator Affiliation	Cross Cancer Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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 cycles.

Active Comparator: 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 cycles.

Interventions

Radiation: - Hypofractionated radiation therapy

Radiation: - Standard radiation therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cross Cancer Institute, Edmonton, Alberta, Canada

Status

Recruiting

Address

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2

Site Contact

Samir Patel, MD

samir.patel2@albertahealthservices.ca

780-432-8518

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