Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-01-31

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).

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: prolonged adj TMZ

Group Type ACTIVE_COMPARATOR

Temozolomide

Intervention Type DRUG

Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD

B : Stop and Go

Rechallenging patients with TMZ at relapse

Group Type OTHER

Temozolomide

Intervention Type DRUG

Observation till Progression then rechallenging with TMZ

Interventions

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Temozolomide

Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD

Intervention Type DRUG

Temozolomide

Observation till Progression then rechallenging with TMZ

Intervention Type DRUG

Other Intervention Names

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TEMODAR, TEMODAL TEMODAR, TEMODAL

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically confirmed diagnosis of GBM
2. Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended
3. 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.
4. A brain MRI with or without a PET-Scan-methionine must be performed before enrolment.
5. Age ≥ 18 years
6. Karnofsky Performance status ≥ 60
7. Normal haematological functions: ANC ≥ 1.5 x 109cells/l, platelets ≥ 100 x 109 cells/l
8. 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
9. Serum creatinine \< 1.5 x ULN
10. 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
11. No previous or current malignancy (except treated basal or squamous cell skin carcinoma, cervix cancer or in situ carcinoma of the breast).
12. All patients (male and female) with reproductive potential must use effective contraception. Females must have a negative serum pregnancy test at entry to study.
13. Signed informed consent from the patient or legal representative must be obtained.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No