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Temozolomide in Elderly Patients With KPS < 70 (TAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01242566
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : November 17, 2010
Sponsor:
Collaborator:
Association de Neuro-Oncologues d’Expression Francaise
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE November 16, 2010
First Posted Date  ICMJE November 17, 2010
Last Update Posted Date November 17, 2010
Study Start Date  ICMJE July 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2010)
Overall survival [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2010)
  • Progression-free survival [ Time Frame: 12 months ]
  • adverse events [ Time Frame: 12 months ]
    term, grade, frequency
  • Health-related quality of life [ Time Frame: 12 months ]
    KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)
  • Cognitive functioning [ Time Frame: 12 months ]
    characterized by MMSE
  • Efficacy according to MGMT Promoter methylation status [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temozolomide in Elderly Patients With KPS < 70
Official Title  ICMJE Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Brain Tumor
  • Glioblastoma
Intervention  ICMJE Drug: Temozolomide
orally 150-200 mg/m2/day for 5 consecutive days every 4 week
Other Name: Temodar, Temodal
Study Arms  ICMJE 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
Intervention: Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2010)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01242566
Other Study ID Numbers  ICMJE P060102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabelle Brindel, Department Clinical Research
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Association de Neuro-Oncologues d’Expression Francaise
Investigators  ICMJE
Principal Investigator: DELATTRE Jean-Yves, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP