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

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ClinicalTrials.gov Identifier: NCT00643825
Recruitment Status : Unknown
Verified July 2010 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : March 26, 2008
Last Update Posted : July 23, 2010
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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).

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Temozolomide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2008
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. safety and adverse event profile of prolonged adjuvant Temozolomide [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010

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, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents