A randomized multicentric phase II study of prolonged adjuvant Temozolomide or stop and go in glioblastoma patients : the PATSGO study. - the PATSGO study

Phase 1

• Conditions: It is an open-label, randomised multicentric phase II study of prolonged adjuvant Temozolomide versus stop and go in glioblastoma patients. This study will include a total of 70 patients. The study will determine the time to progression under TMZ, overall survival,progression-free survival (PFS),quality of life of patients. It will also determine the toxicity,response rate of Temozolomide in rechallenge arm and if the MGMT gene status can predict a benefit of TMZ in terms of PFS.

• Registration Number: EUCTR2006-004635-30-BE
• Lead Sponsor: CENTRE DU CANCER - CLINIQUES UNIVERSITAIRES SAINT-LUC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-26
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

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 postive must be performed before enrollment.
5)Age = 18 years
6)Karnofsky Performance status =70
7)Normal haematological functions: ANC =1.5*109cells/l, platelets =100*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 ischaemic heart disease
in the past 12 months. Absence of cardiac insufficiency NYHA grade III and
IV, instable angina, arrhythmia
11)No active malignancy (except treated basal or squamous cell skin carcinoma).
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All non inclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified