Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).
70 Years
N/A
Both
Primary Brain Tumor, Glioblastoma
Trial Information
Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
DELATTRE Jean-Yves, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P060102
NCT ID:
NCT01242566
Start Date:
July 2007
Completion Date:
September 2010
Related Keywords:
- Primary Brain Tumor
- Glioblastoma
- Temozolomide
- Elderly
- Glioblastoma
- Karnofsky performance score (KPS)
- Brain Neoplasms
- Glioblastoma
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