TAG: Temozolomide in Elderly Patients With KPS < 70

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01242566

Collaborator

Association de Neuro-Oncologues d'Expression Francaise (Other)

Enrollment

Location

Arm

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Brain Tumor Glioblastoma	Drug: Temozolomide	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Temozolomide orally 150-200 mg/m2/day for 5 consecutive days every 4 week Other Names: Temodar, Temodal

Arm

Intervention/Treatment

Experimental: 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

Drug: Temozolomide

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

Other Names:

Temodar, Temodal

Outcome Measures

Primary Outcome Measures

Overall survival [12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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