Abstract
On the basis of reported successful hormone therapy for recurrent cancer of the endometrium, a multi-institutional program was established in 1963 and terminated in 1968 to study the adjuvant use of a progestogen in the primary definitive treatment of uterine carcinoma. The research protocol restricted entry to patients with disease limited to the uterine corpus as established by clinical evaluation, surgery, and pathology. Option of surgery alone or surgery plus irradiation was permitted. Depo-Provera and placebo given over 14 wk were randomly assigned in such a way that 285 patients received hormone; 287 served as controls. Survival analysis at 4 yr indicated no significant contribution to results by the adjuvant therapy. Overall excellent survival for treated patients and controls appeared to be the result of the high degree of patient selection incorporated in the protocol design. The influence of patient selection and of variations of disease-related parameters upon the results is discussed especially as it may affect future programs dealing with comparable patient material.
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