Suspended
A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma
What is being tested
TMZ plus concurrent re-irradiation
+ Temozolomide
+ TMZ plus concurrent re-irradiation
Drug
Who is being recruted
Astrocytoma+7
+ Glioma
+ Neoplasms
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: February 2014
Summary
Principal SponsorAHS Cancer Control Alberta
Last updated: March 16, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2014
Actual date on which the first participant was enrolled.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.
Principal SponsorAHS Cancer Control Alberta
Last updated: March 16, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AstrocytomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, NeuroepithelialGlioblastoma
Criteria
5 inclusion criteria required to participate
18 years or older
ECOG 0 - 2
histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
radiographic evidence of tumour progression or recurrence
Show More Criteria
5 exclusion criteria prevent from participating
6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
more than one prior course of salvage chemo for recurrent disease
prior head or neck RT except for T1 glottic cancer
prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTMZ plus concurrent re-irradiation
Group II
ExperimentalTMZ alone
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center