Prolonged Adjuvant Temozolomide vs Stop & Go in Glioblastoma Patients

Study Overview
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Brief Summary
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This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).

Official Title
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Randomized Multicentric Phase II Study of Prolonged Adjuvant Temozolomide or Stop and Go in Glioblastoma Patients: The PATSGO Study

Conditions
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Glioblastoma

Intervention / Treatment
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* Drug: Temozolomide
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed diagnosis of GBM Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended Patients must have received radiation and TMZ for 6 weeks followed by 6 months of TMZ. Randomization should be performed within the 6 weeks after the last chemotherapy. A brain MRI with or without a PET-Scan-methionine must be performed before enrolment. Age ≥ 18 years Karnofsky Performance status ≥ 60 Normal haematological functions: ANC ≥ 1.5 x 109cells/l, platelets ≥ 100 x 109 cells/l Normal liver function: total bilirubin < 1.5 x ULN, alkaline phosphatase and transaminases (ASAT/ALAT) < 2.5 times the upper limit of the normal range Serum creatinine < 1.5 x ULN Clinically normal cardiac function without history of ischemic heart disease in the past 12 months. Absence of cardiac insufficiency NYHA grade III and IV, instable angina, arrhythmia No previous or current malignancy (except treated basal or squamous cell skin carcinoma, cervix cancer or in situ carcinoma of the breast). All patients (male and female) with reproductive potential must use effective contraception. Females must have a negative serum pregnancy test at entry to study. Signed informed consent from the patient or legal representative must be obtained. Exclusion Criteria: All non inclusion criteria

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 |
| --- | --- |
| Active Comparator: A: prolonged adj TMZ<br> | Drug: Temozolomide<br>* Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD<br>* Other names: TEMODAR, TEMODAL;|
| Other: B : Stop and Go<br>Rechallenging patients with TMZ at relapse | Drug: Temozolomide<br>* Observation till Progression then rechallenging with TMZ<br>* Other names: TEMODAR, TEMODAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and adverse event profile of prolonged adjuvant Temozolomide |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temozolomide, Phase II, Chemotherapy, Glioblastoma, Progression-free Survival