Temozolomide in Elderly Patients With KPS < 70 (TAG)
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|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|
|Actual Primary Completion Date :||May 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|