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

Glioblastoma Clinical Trial

— PATSGO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00643825
• Other study ID #: UCL-ONCO 06-004
• Status: Recruiting
• Phase: Phase 2
• First received: March 20, 2008
• Last updated: July 22, 2010
• Start date: January 2008
• Est. completion date: January 2012

Study information

• Verified date: July 2010
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Jean-Francois BAURAIN, MD, PhD
• Phone: +32 2 764 54 71
• Email: jean-francois.baurain[@]uclouvain.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• Temozolomide
Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
• Temozolomide
Observation till Progression then rechallenging with TMZ

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels	Europe

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months		36 months	Yes
Secondary	safety and adverse event profile of prolonged adjuvant Temozolomide		3 years	Yes