We elected to examine available information from several sources to ap
proximate the annual number of cases of vaginal adenocarcinoma in the
United States for recent years. Data were obtained from the Registry o
n Hormonal Transplacental Carcinogenesis, the Surveillance, Epidemiolo
gy and End Results (SEER) program of the National Cancer Institute, th
e National Cancer Databank of the American College of Surgeons Commiss
ion on Cancer, and a survey of gynecologic oncologists practicing in t
he United States. In 1990 a total of 33 new cases and 11 recurrences w
ere reported, while in 1991 23 new cases and 8 recurrences were report
ed. Neither SEER nor the Registry appear to provide adequate surveilla
nce for this rare disease. Phase III clinical trials are not feasible,
given the small number of patients. Statistically effective phase II
one-armed studies to investigate new agents in the treatment of advanc
ed or recurrent vaginal clear cell cancer may be possible. Effective m
obilization of patients and physicians will be required for such trial
s to be completed in a timely manner. (C) 1996 Academic Press, Inc.