Status:
COMPLETED
Temozolomide in Elderly Patients With KPS < 70
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Association de Neuro-Oncologues d'Expression Francaise
Conditions:
Primary Brain Tumor
Glioblastoma
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
The management of glioblastoma in elderly patients with poor performance status (KPS\<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolo...
Detailed Description
This trial was conducted to evaluate the efficacy, in terms of survival and quality of life, and safety of up-front temozolomide in elderly GBM patients with poor performance status. Patients of 70 y...
Eligibility Criteria
Inclusion
- Histologically confirmed supratentorial glioblastoma
- Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy
- Patients aged 70 years or older
- KPS above 30 and below 70
- Life expectancy higher than 4 weeks
- Clinical examination at baseline
- Affiliation to Social Security or mandatory beneficiary
- Patient being informed and obtention of written informed consent
Exclusion
- Prior surgical resection dated more than 1 month before inclusion
- Prior brain radiotherapy or chemotherapy
- Severe underlying disease which could interfere with survival
- History of hypersensibility reaction on temozolomide components
- Severe bone marrow hypoplasia
- Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal
- Absolute neutrophil count \< 1.5x109 cells per liter
- Platelet count \< 100x109 cells per liter
- Hemoglobin \< 9 g/dl
- Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01242566
Start Date
July 1 2007
End Date
September 1 2010
Last Update
November 17 2010
Active Locations (1)
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1
Pitie salpetriere hospital
Paris, France, 75013