A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

March 14, 2016 updated by: AHS Cancer Control Alberta

A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TMZ plus concurrent re-irradiation
Drug: TMZ plus concurrent re-irradiation
Other Names:
  • Temedol
Drug: Temozolomide
low-dose temozolomide daily for one year
Other Names:
  • Temedol
EXPERIMENTAL: TMZ alone
Drug: TMZ plus concurrent re-irradiation
Other Names:
  • Temedol
Drug: Temozolomide
low-dose temozolomide daily for one year
Other Names:
  • Temedol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Investigators

  • Principal Investigator: Samir Patel, MD, Cross Cancer Institute
  • Principal Investigator: Gerald Lim, MD, Tom Baker Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

November 1, 2017

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (ESTIMATE)

April 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCI-Patel-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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