A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

Recurrent Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01830101
• Other study ID #: CCI-Patel-01
• Status: Withdrawn
• Phase: Phase 3
• First received: March 13, 2013
• Last updated: March 14, 2016
• Start date: February 2014
• Est. completion date: November 2017

Study information

• Verified date: February 2014
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

Intervention

Drug:
• TMZ plus concurrent re-irradiation

• Temozolomide
low-dose temozolomide daily for one year

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.		2 months	No