Glioblastoma
Conditions
Keywords
Temozolomide, Phase II, Chemotherapy, Glioblastoma, Progression-free Survival
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 every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).
Interventions
DRUGTemozolomide
Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
All non inclusion criteria
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| safety and adverse event profile of prolonged adjuvant Temozolomide | 3 years |
Countries
Belgium
Contacts
Primary ContactJean-Francois BAURAIN, MD, PhD
Outcome results
None listed