A Phase 2 interventional study of Temozolomide in Primary Brain Tumor and Glioblastoma, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2010-11-17.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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
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.
1,919 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.
This study's enrollment of 70 is above the median of 36 across 1,617 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,504 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: Temodar, Temodal
Overall survival
Time frame: 12 months
Progression-free survival
Time frame: 12 months
adverse events
term, grade, frequency
Time frame: 12 months
Health-related quality of life
KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)
Time frame: 12 months
Cognitive functioning
characterized by MMSE
Time frame: 12 months
Efficacy according to MGMT Promoter methylation status
Time frame: 12 months
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris