Status:
UNKNOWN
Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 e...
Eligibility Criteria
Inclusion
- 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
- All non inclusion criteria
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00643825
Start Date
January 1 2008
End Date
January 1 2012
Last Update
July 23 2010
Active Locations (1)
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1
Cliniques Universitaires Saint-Luc
Brussels, Europe, Belgium, 1200