Trial Information
A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
Outcome Time Frame:
2 months
Safety Issue:
No
Principal Investigator
Samir Patel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cross Cancer Institute
Authority:
Canada: Health Canada
Study ID:
CCI-Patel-01
NCT ID:
NCT01830101
Start Date:
May 2013
Completion Date:
November 2017
Related Keywords:
- Recurrent Glioblastoma
- recurrent glioblastoma
- re-irradiation
- continuous low-dose temozolomide
- Glioblastoma