A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01830101

Enrollment

Registered

2013-04-12

Start date

2014-02-28

Completion date

2017-11-30

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Glioblastoma

Keywords

recurrent glioblastoma, re-irradiation, continuous low-dose temozolomide

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.

Interventions

DRUGTMZ plus concurrent re-irradiation

DRUGTemozolomide

low-dose temozolomide daily for one year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026