Temozolomide in Elderly Patients With KPS < 70

Glioblastoma Clinical Trial

— TAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242566
• Other study ID #: P060102
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2010
• Last updated: November 16, 2010
• Start date: July 2007
• Est. completion date: September 2010

Study information

• Verified date: November 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Primary Brain Tumor

Intervention

Drug:
• Temozolomide
orally 150-200 mg/m2/day for 5 consecutive days every 4 week

Locations

Country	Name	City	State
France	Pitie salpetriere hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Association de Neuro-Oncologues d’Expression Francaise

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		12 months	No
Secondary	Progression-free survival		12 months	No
Secondary	adverse events	term, grade, frequency	12 months	Yes
Secondary	Health-related quality of life	KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)	12 months	No
Secondary	Cognitive functioning	characterized by MMSE	12 months	No
Secondary	Efficacy according to MGMT Promoter methylation status		12 months	No