Temozolomide in Elderly Patients With KPS < 70

Phase 2

Completed

• Conditions: Primary Brain Tumor; Glioblastoma
• Interventions: Drug: Temozolomide

• Registration Number: NCT01242566
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 temozolomide alone in this population

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 years of age or older were eligible to participate in this prospective non-randomised multicentric phase II study if they had newly diagnosed and histologically proven glioblastoma on the basis of the WHO classification, and a postoperative KPS between 30 and 60.

Treatment consisted of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity.

Patients were assessed at least every month by means of physical and neurological examinations, KPS, health-related EORTC questionnaires (QLQ-C30 and QLQ-BN20), and MMSE. Complete blood counts and blood chemistry were drawn before each temozolomide cycle; the earlier were also checked every 10 days during the first 2 cycles and every 2 weeks afterwards. CT or MRI studies were repeated every 2 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-07
• Status Verified: 2009-11
• Primary Completion: 2010-05
• Study Completion: 2010-09
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Last Update Submitted: 2010-11-16
• Study First Posted: 2010-11-17
• Last Update Posted: 2010-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
temozolomide	Temozolomide	Administration of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity

Primary Outcome Measures

Name	Time	Method
Overall survival	12 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	12 months
adverse events	12 months	term, grade, frequency
Health-related quality of life	12 months	KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)
Cognitive functioning	12 months	characterized by MMSE
Efficacy according to MGMT Promoter methylation status	12 months

Trial Locations

Locations (1)

Pitie salpetriere hospital; 🇫🇷 Paris, France