Back to resultsTrial of Hypofractionated Radiation Therapy for Glioblastoma
Primary Purpose
Glioblastoma
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Hypofractionated radiation therapy
Standard radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring glioblastoma, radiotherapy, hypofractionated radiotherapy
Eligibility 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
Sites / Locations
- Cross Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hypofractionated radiation therapy
Standard radiation therapy
Arm 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 cycles.
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.
Outcomes
Primary Outcome Measures
Overall survival
Patients without an event will be censored the last time they were known to be alive
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02206230
First Posted
July 24, 2014
Last Updated
December 31, 2015
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02206230
Brief Title
Trial of Hypofractionated Radiation Therapy for Glioblastoma
Official Title
A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
glioblastoma, radiotherapy, hypofractionated radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionated radiation therapy
Arm Type
Experimental
Arm 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 cycles.
Arm Title
Standard radiation therapy
Arm Type
Active Comparator
Arm 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 cycles.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Standard radiation therapy
Primary Outcome Measure Information:
Title
Overall survival
Description
Patients without an event will be censored the last time they were known to be alive
Time Frame
Up to 24 months from date of randomization to date of death due to any cause
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samir Patel, MD
Phone
780-432-8783
Email
samir.patel2@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Patel, MD
Organizational Affiliation
Cross Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Patel, MD
Phone
780-432-8518
Email
samir.patel2@albertahealthservices.ca
12. IPD Sharing Statement
Citations:
PubMed Identifier
36273738
Citation
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.
Results Reference
derived
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Trial of Hypofractionated Radiation Therapy for Glioblastoma
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