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

NCT00643825 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2010-07-23

No results posted yet for this study

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

DRUG

Temozolomide

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

DRUG

Temozolomide

Observation till Progression then rechallenging with TMZ

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Jean-Francois Baurain, MD, PhD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-01-31
Completion
2012-01-31

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00643825 on ClinicalTrials.gov