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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Unknown status

CT.gov ID

NCT00643825

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Drug: Temozolomide Drug: Temozolomide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Jan 1, 2011

Anticipated Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A: prolonged adj TMZ	Drug: Temozolomide Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD Other Names: TEMODAR, TEMODAL
Other: B : Stop and Go Rechallenging patients with TMZ at relapse	Drug: Temozolomide Observation till Progression then rechallenging with TMZ Other Names: TEMODAR, TEMODAL

Arm

Intervention/Treatment

Active Comparator: A: prolonged adj TMZ

Drug: Temozolomide

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

Other Names:

TEMODAR, TEMODAL

Other: B : Stop and Go

Rechallenging patients with TMZ at relapse

Drug: Temozolomide

Observation till Progression then rechallenging with TMZ

Other Names:

TEMODAR, TEMODAL

Outcome Measures

Primary Outcome Measures

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

safety and adverse event profile of prolonged adjuvant Temozolomide [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.