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


Phase 3
18 Years
N/A
Not Enrolling
Both
Recurrent Glioblastoma

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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

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