Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients (PATSGO)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Unknown; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00643825

UCL-ONCO 06-004

Details and patient eligibility

About

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).

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

A: prolonged adj TMZ

Active Comparator group

Treatment:

Drug: Temozolomide

Drug: Temozolomide

B : Stop and Go

Other group

Description:

Rechallenging patients with TMZ at relapse

Treatment:

Drug: Temozolomide

Drug: Temozolomide