A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

Phase 3

Withdrawn

• Conditions: Recurrent Glioblastoma
• Interventions: Drug: TMZ plus concurrent re-irradiation; Drug: Temozolomide

• Registration Number: NCT01830101
• Lead Sponsor: AHS Cancer Control Alberta

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-12
• Status Verified: 2014-02
• Study Start: 2014-02
• Primary Completion: 2015-05
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMZ plus concurrent re-irradiation	TMZ plus concurrent re-irradiation	TMZ plus concurrent re-irradiation
TMZ alone	TMZ plus concurrent re-irradiation	TMZ alone
TMZ plus concurrent re-irradiation	Temozolomide	TMZ plus concurrent re-irradiation
TMZ alone	Temozolomide	TMZ alone

Primary Outcome Measures

Name	Time	Method
To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.	2 months

Secondary Outcome Measures

Name	Time	Method
To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.	2 months

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada