Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
Condition: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer
MeSH terms: Liver Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and
      gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
      may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It
      is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is
      more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic
      biliary tract cancer.

      PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and
      radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in
      treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.
    

Detailed description: 
      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.
    

Intervention name(s): cisplatin; gemcitabine hydrochloride; oxaliplatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: localized unresectable adult primary liver cancer; unresectable extrahepatic bile duct cancer; unresectable gallbladder cancer