Phase III Trial of Primary Radio- or Chemotherapy in Malignant Astrocytoma of the Elderly

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to optimize the treatment of elderly subjects (> 65) with anaplastic astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative. There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is the treatment most likely to be accepted apart from supportive and palliative measures. The role of chemotherapy is barely defined. Study data available to date does not suggest that this patient population would benefit from combined radiochemotherapy. The aim of the study is to verify the hypothesis that first-line chemotherapy with one week on/one week off temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of anaplastic astrocytoma and glioblastoma in the elderly (> 65 age group). The primary endpoint is median survival, as life expectancy is limited to several months. Secondary endpoints are response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic prognostic or predictive markers, and quality of life. Theoretically, it should be possible to preserve quality of life in the first-line chemotherapy arm of the study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

• Histologically confirmed supratentorial anaplastic astrocytoma or glioblastoma

• Age > 65

• Karnofsky performance score > 60%

• Neutrophilic granulocyte count > 1500/µl

• Platelet count > 100 000/µl

• Hemoglobin > 10 g/dl

• Serum creatinine < 1.5 times the lab's upper normal limit

• AST or ALT < 3 times the lab's upper normal limit

• Alkaline phosphatase < 3 times the lab's upper normal limit

• No previous systemic chemotherapy

• No previous radiotherapy to the brain

• Written consent

Exclusion Criteria:

• Serious medical or neurological condition with a poor prognosis

• HIV infection

• Second cancer requiring radiotherapy or chemotherapy (contact the study coordinat if necessary)

• Hypersensitivity to temozolomide

• Conditions associated with regular vomiting that might affect oral administration of the drugs

• Psychological, familial, social or geographical circumstances with major implications for compliance with the study visit schedule

• Patient was taking part in other intervention studies within a month of starting this study