Clinical Trials Directory

Trials / Unknown

UnknownNCT00643825

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

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

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
64 (estimated)
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGTemozolomideCapsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
DRUGTemozolomideObservation till Progression then rechallenging with TMZ

Timeline

Start date
2008-01-01
Primary completion
2011-01-01
Completion
2012-01-01
First posted
2008-03-26
Last updated
2010-07-23

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT00643825. Inclusion in this directory is not an endorsement.