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A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01830101
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 AHS Cancer Control Alberta
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Samir Patel, MDGerald Lim, MD
Principal Investigator Affiliation Cross Cancer InstituteTom Baker Cancer Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Withdrawn
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: TMZ plus concurrent re-irradiation

TMZ plus concurrent re-irradiation

Experimental: TMZ alone

TMZ alone

Interventions

Drug: - TMZ plus concurrent re-irradiation

Drug: - Temozolomide

low-dose temozolomide daily for one year

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cross Cancer Institute, Edmonton, Alberta, Canada

Status

Address

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2

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