Clinical trial NCT01242566: Temozolomide in Elderly Patients With KPS < 70
Official title: Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Brain Tumor
Glioblastoma
Keywords: Temozolomide
Elderly
Glioblastoma
Karnofsky performance score (KPS)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association de Neuro-Oncologues d'Expression Francaise
First posted: 2010-11-17
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 12 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 12 months
measure: adverse events
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 12 months
measure: Cognitive functioning
timeFrame: 12 months
measure: Efficacy according to MGMT Promoter methylation status
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitie salpetriere hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: DELATTRE Jean-Yves, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: