Trial Information

A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators

OBJECTIVES:

- Compare the benefit of early chemotherapy based on CA 125 level only vs chemotherapy
based on conventional clinical indicators in patients with relapsed ovarian epithelial,
fallopian tube, or primary peritoneal cancer.

- Compare the overall survival of patients treated with these regimens.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients whose CA 125 levels rise to more
than two times the upper limit of normal are randomized to one of two treatment arms.

- Arm I: The clinician is informed of the initial rise in CA 125 level. A confirmatory
test is performed immediately. Within 4 weeks of the initial CA 125 elevation, patients
with a second confirmed elevation receive treatment for recurrent disease according to
standard local practice. Patients with a normal CA 125 on the confirmatory test receive
no treatment until clinically indicated.

- Arm II: The clinician is blinded to the CA 125 results. Patients undergo normal
monitoring. When clinically indicated, patients commence treatment according to
standard local practice.

Quality of life is assessed at baseline, at each follow-up visit, and, if treatment is
instituted, before each chemotherapy course.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.