Phase III Trial of Primary Radio- or Chemotherapy in Malignant Astrocytoma of the Elderly
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
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.