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A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

This study has been withdrawn prior to enrollment.
(This study will not be proceeding due to lack of funding from anticipated sources)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830101
First Posted: April 12, 2013
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  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.

Condition Intervention Phase
Recurrent Glioblastoma Drug: TMZ plus concurrent re-irradiation Drug: Temozolomide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

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. [ Time Frame: 2 months ]

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. [ Time Frame: 2 months ]

Enrollment: 0
Study Start Date: February 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMZ plus concurrent re-irradiation
TMZ plus concurrent re-irradiation
Drug: TMZ plus concurrent re-irradiation
Other Name: Temedol
Drug: Temozolomide
low-dose temozolomide daily for one year
Other Name: Temedol
Experimental: TMZ alone
TMZ alone
Drug: TMZ plus concurrent re-irradiation
Other Name: Temedol
Drug: Temozolomide
low-dose temozolomide daily for one year
Other Name: Temedol

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830101


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Samir Patel, MD Cross Cancer Institute
Principal Investigator: Gerald Lim, MD Tom Baker Cancer Centre
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01830101     History of Changes
Other Study ID Numbers: CCI-Patel-01
First Submitted: March 13, 2013
First Posted: April 12, 2013
Last Update Posted: March 16, 2016
Last Verified: February 2014

Keywords provided by AHS Cancer Control Alberta:
recurrent glioblastoma
re-irradiation
continuous low-dose temozolomide

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents