Back to resultsA Phase III Study of Re-Irradiation in Recurrent Glioblastoma
Primary Purpose
Recurrent Glioblastoma
Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
TMZ plus concurrent re-irradiation
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring recurrent glioblastoma, re-irradiation, continuous low-dose temozolomide
Eligibility Criteria
Inclusion Criteria:
- histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
- radiographic evidence of tumour progression or recurrence
- 18 years or older
- ECOG 0 - 2
- signed informed consent form
Exclusion Criteria:
- tumour progression or recurrence within 3 months of initial concurrent chemoradiation
- 6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
- more than one prior course of salvage chemo for recurrent disease
- prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
- prior head or neck RT except for T1 glottic cancer
Sites / Locations
- Cross Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TMZ plus concurrent re-irradiation
TMZ alone
Arm Description
TMZ plus concurrent re-irradiation
TMZ alone
Outcomes
Primary Outcome Measures
To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
Secondary Outcome Measures
To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.
Full Information
NCT ID
NCT01830101
First Posted
March 13, 2013
Last Updated
March 14, 2016
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT01830101
Brief Title
A Phase III Study of Re-Irradiation in Recurrent Glioblastoma
Official Title
A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
This study will not be proceeding due to lack of funding from anticipated sources
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.
Detailed Description
This is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. Patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
Keywords
recurrent glioblastoma, re-irradiation, continuous low-dose temozolomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMZ plus concurrent re-irradiation
Arm Type
Experimental
Arm Description
TMZ plus concurrent re-irradiation
Arm Title
TMZ alone
Arm Type
Experimental
Arm Description
TMZ alone
Intervention Type
Drug
Intervention Name(s)
TMZ plus concurrent re-irradiation
Other Intervention Name(s)
Temedol
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temedol
Intervention Description
low-dose temozolomide daily for one year
Primary Outcome Measure Information:
Title
To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
radiographic evidence of tumour progression or recurrence
18 years or older
ECOG 0 - 2
signed informed consent form
Exclusion Criteria:
tumour progression or recurrence within 3 months of initial concurrent chemoradiation
6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
more than one prior course of salvage chemo for recurrent disease
prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
prior head or neck RT except for T1 glottic cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Patel, MD
Organizational Affiliation
Cross Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerald Lim, MD
Organizational Affiliation
Tom Baker Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of Re-Irradiation in Recurrent Glioblastoma
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