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
Recruitment status was Recruiting
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
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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:
- 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.
Exclusion Criteria:
All non inclusion criteria
Contacts and Locations
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, 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 Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013