Trial Information

Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract

OBJECTIVES:

Primary

- Compare the 3-month progression rate in patients with unresectable, nonmetastatic
cancer of the biliary tract treated with fluorouracil, cisplatin, and radiotherapy vs
gemcitabine hydrochloride and oxaliplatin. (phase II)

- Compare the overall survival of patients treated with these regimens. (phase III)

Secondary

- Compare toxicities of these regimens in these patients. (phase II)

- Compare the quality of life at initial drainage (phase II) and overall (phase III) of
patients treated with these regimens.

- Compare the biliary complication rate in patients treated with these regimens.

- Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease location (gallbladder vs intrahepatic biliary duct vs extrahepatic biliary duct).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy once daily, 5 days a week on days 1-33. Patients
also receive fluorouracil IV continuously over 5 days once a week in weeks 1-5 and
cisplatin IV over 15 minutes on days 1-4 and 29-32 (or days 1 or 2 and 29 or 30) in the
absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes and oxaliplatin
IV over 2 hours on day 1. Treatment repeats every 14 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months thereafter.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.