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