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Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients (PATSGO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00643825
First Posted: March 26, 2008
Last Update Posted: July 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
March 20, 2008
March 26, 2008
July 23, 2010
January 2008
January 2011   (Final data collection date for primary outcome measure)
to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months [ Time Frame: 36 months ]
to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months [ Time Frame: 24months ]
Complete list of historical versions of study NCT00643825 on ClinicalTrials.gov Archive Site
safety and adverse event profile of prolonged adjuvant Temozolomide [ Time Frame: 3 years ]
safety and adverse event profile of prolonged adjuvant Temozolomide [ Time Frame: 2 years ]
Not Provided
Not Provided
 
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
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glioblastoma
  • Drug: Temozolomide
    Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
    Other Name: TEMODAR, TEMODAL
  • Drug: Temozolomide
    Observation till Progression then rechallenging with TMZ
    Other Name: TEMODAR, TEMODAL
  • Active Comparator: A: prolonged adj TMZ
    Intervention: Drug: Temozolomide
  • B : Stop and Go
    Rechallenging patients with TMZ at relapse
    Intervention: Drug: Temozolomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
64
January 2012
January 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00643825
UCL-ONCO 06-004
Yes
Not Provided
Not Provided
Prof Baurain J-Fr, Cliniques universitaires Saint-Luc
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Not Provided
Principal Investigator: Jean-Francois Baurain, MD, PhD Cliniques universitaires Saint-Luc
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP