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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00643825
First received: March 20, 2008
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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).


Condition Intervention Phase
Glioblastoma
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Multicentric Phase II Study of Prolonged Adjuvant Temozolomide or "Stop and Go" in Glioblastoma Patients: The PATSGO Study

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety and adverse event profile of prolonged adjuvant Temozolomide [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: January 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A: prolonged adj TMZ Drug: Temozolomide
Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
Other Name: TEMODAR, TEMODAL
B : Stop and Go
Rechallenging patients with TMZ at relapse
Drug: Temozolomide
Observation till Progression then rechallenging with TMZ
Other Name: TEMODAR, TEMODAL

Detailed Description:

/

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643825

Contacts
Contact: Jean-Francois BAURAIN, MD, PhD +32 2 764 54 71 jean-francois.baurain@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Europe, Belgium, 1200
Contact: Jean-Francois BAURAIN, MD, PhD    +32 2 764 54 71    jean-francois.baurain@@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Jean-Francois Baurain, MD, PhD Cliniques universitaires Saint-Luc
  More Information

No publications provided

Responsible Party: Prof Baurain J-Fr, Cliniques universitaires Saint-Luc
ClinicalTrials.gov Identifier: NCT00643825     History of Changes
Other Study ID Numbers: UCL-ONCO 06-004
Study First Received: March 20, 2008
Last Updated: July 22, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Temozolomide
Phase II
Chemotherapy
Glioblastoma
Progression-free Survival

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014