Know Cancer

forgot password

Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).

Phase 2
70 Years
Not Enrolling
Primary Brain Tumor, Glioblastoma

Thank you

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:


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:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

July 2007

Completion Date:

September 2010

Related Keywords:

  • Primary Brain Tumor
  • Glioblastoma
  • Temozolomide
  • Elderly
  • Glioblastoma
  • Karnofsky performance score (KPS)
  • Brain Neoplasms
  • Glioblastoma