Temozolomide in Elderly Patients With KPS < 70 (TAG)
|ClinicalTrials.gov Identifier: NCT01242566|
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : November 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Primary Brain Tumor Glioblastoma||Drug: Temozolomide||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).|
|Study Start Date :||July 2007|
|Primary Completion Date :||May 2010|
|Study Completion Date :||September 2010|
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
orally 150-200 mg/m2/day for 5 consecutive days every 4 week
Other Name: Temodar, Temodal
- Overall survival [ Time Frame: 12 months ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242566
|Pitie salpetriere hospital|
|Paris, France, 75013|
|Principal Investigator:||DELATTRE Jean-Yves, MD, PhD||Assistance Publique - Hôpitaux de Paris|