A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Glioblastoma

Intervention / Treatment
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* Drug: TMZ plus concurrent re-irradiation
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMZ plus concurrent re-irradiation<br>TMZ plus concurrent re-irradiation | Drug: TMZ plus concurrent re-irradiation<br> <br> * Other names: Temedol;Drug: Temozolomide<br>* low-dose temozolomide daily for one year<br>* Other names: Temedol;|
| Experimental: TMZ alone<br>TMZ alone | Drug: TMZ plus concurrent re-irradiation<br> <br> * Other names: Temedol;Drug: Temozolomide<br>* low-dose temozolomide daily for one year<br>* Other names: Temedol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent glioblastoma, re-irradiation, continuous low-dose temozolomide