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Temozolomide in Elderly Patients With KPS < 70 (TAG)

This study has been completed.
Sponsor:
Collaborator:
ANOCEF (Association des Neuro-Oncologues d'Expression Française)
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01242566
First received: November 16, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention Phase
Primary Brain Tumor
Glioblastoma
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    term, grade, frequency

  • Health-related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)

  • Cognitive functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    characterized by MMSE

  • Efficacy according to MGMT Promoter methylation status [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: July 2007
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Temodar, Temodal

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242566

Locations
France
Pitie salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ANOCEF (Association des Neuro-Oncologues d'Expression Française)
Investigators
Principal Investigator: DELATTRE Jean-Yves, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Isabelle Brindel, Department Clinical Research
ClinicalTrials.gov Identifier: NCT01242566     History of Changes
Other Study ID Numbers: P060102
Study First Received: November 16, 2010
Last Updated: November 16, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Temozolomide
Elderly
Glioblastoma
Karnofsky performance score (KPS)

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014