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Temozolomide in Elderly Patients With KPS < 70

NCT ID: NCT01242566

Last Updated: 2010-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Primary Brain Tumor Glioblastoma

Keywords

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Temozolomide Elderly Glioblastoma Karnofsky performance score (KPS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

orally 150-200 mg/m2/day for 5 consecutive days every 4 week

Interventions

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Temozolomide

orally 150-200 mg/m2/day for 5 consecutive days every 4 week

Intervention Type DRUG

Other Intervention Names

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Temodar, Temodal

Eligibility Criteria

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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

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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association de Neuro-Oncologues d'Expression Francaise

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research

Principal Investigators

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DELATTRE Jean-Yves, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Pitie salpetriere hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P060102

Identifier Type: -

Identifier Source: org_study_id