NCT00643825

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 23, 2010

Status Verified

July 1, 2010

Enrollment Period

3 years

First QC Date

March 20, 2008

Last Update Submit

July 22, 2010

Conditions

Glioblastoma

Keywords

TemozolomidePhase IIChemotherapyGlioblastomaProgression-free Survival

Outcome Measures

Primary Outcomes (1)

  • to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months

    36 months

Secondary Outcomes (1)

  • safety and adverse event profile of prolonged adjuvant Temozolomide

    3 years

Study Arms (2)

A: prolonged adj TMZ

ACTIVE COMPARATOR
Drug: Temozolomide

B : Stop and Go

OTHER

Rechallenging patients with TMZ at relapse

Drug: Temozolomide

Interventions

TemozolomideDRUG

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

Also known as: TEMODAR, TEMODAL
A: prolonged adj TMZ

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, Europe, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean-Francois Baurain, MD, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Francois BAURAIN, MD, PhD

CONTACT

+32 2 764 54 71jean-francois.baurain@uclouvain.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

July 23, 2010

Record last verified: 2010-07

Locations

BE(1)