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Temozolomide in Elderly Patients With KPS < 70 (TAG)

Primary Purpose

Primary Brain Tumor, Glioblastoma

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Temozolomide

About this trial

This is an interventional treatment trial for Primary Brain Tumor focused on measuring Temozolomide, Elderly, Glioblastoma, Karnofsky performance score (KPS)

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Pitie salpetriere hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

temozolomide

Arm Description

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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival

adverse events

term, grade, frequency

Health-related quality of life

KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)

Cognitive functioning

characterized by MMSE

Efficacy according to MGMT Promoter methylation status

Full Information

NCT ID

NCT01242566

First Posted

November 16, 2010

Last Updated

November 16, 2010

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Association de Neuro-Oncologues d'Expression Francaise

1. Study Identification

Unique Protocol Identification Number

NCT01242566

Brief Title

Temozolomide in Elderly Patients With KPS < 70

Acronym

TAG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Association de Neuro-Oncologues d'Expression Francaise

4. Oversight

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Brain Tumor, Glioblastoma

Keywords

Temozolomide, Elderly, Glioblastoma, Karnofsky performance score (KPS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

temozolomide

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodar, Temodal

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Progression-free survival

Time Frame

12 months

Title

adverse events

Description

term, grade, frequency

Time Frame

12 months

Title

Health-related quality of life

Description

KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)

Time Frame

12 months

Title

Cognitive functioning

Description

characterized by MMSE

Time Frame

12 months

Title

Efficacy according to MGMT Promoter methylation status

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

DELATTRE Jean-Yves, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pitie salpetriere hospital

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

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Temozolomide in Elderly Patients With KPS < 70

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