Trial Information

Multicenter Study of the Quality of Life of Patients With Invasive Urothelial Cancer Treated With Conservative Surgery Followed by Cisplatin, Fluorouracil and Radiotherapy

OBJECTIVES: I. Assess the quality of life of patients with invasive stage II, III, or IV
carcinoma of the urothelium treated with conservative surgery plus cisplatin, fluorouracil,
and radiotherapy. II. Determine the efficacy of this regimen, in terms of local control, in
these patients. III. Determine survival of patients treated with this regimen. IV. Determine
the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type
(T2-4a, N0, M0; potentially resectable; no contraindication to surgery vs T2-4b, N0 or N1 or
pN1, M0; refused surgery or medical contraindications to surgery). (Accrual for stratum I
was completed as of 10/23/2001.) Stratum I (resectable disease): Regimen A: Patients undergo
radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously
and cisplatin IV continuously on days 1-4 during weeks 1 and 4. If complete response is
achieved by week 5, patients proceed to regimen B. If partial response or progression is
observed, patients undergo cystectomy. If cystectomy is refused, patients proceed to regimen
B. Regimen B: Patients undergo radiotherapy 5 days a week for 2 weeks. Patients also receive
fluorouracil and cisplatin as in regimen A on weeks 2 and 5. (Accrual for stratum I was
completed as of 10/23/2001.) Stratum II (unresectable disease): Patients undergo
radiotherapy 5 days a week for 7 weeks. Patients also receive fluorouracil and cisplatin as
in regimen A on weeks 1, 4, and 7. Quality of life is assessed at baseline, at 6 months, and
then at 1 year. Patients are followed at 6-8 weeks, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients (35 for stratum I and 40 for stratum II) will be
accrued for this study. (Accrual for stratum I was completed as of 10/23/2001.)