Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery
Condition: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer
MeSH terms: Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Observation is watching a patient's condition but not giving
      treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride
      together with oxaliplatin is more effective than observation in treating patients with
      biliary tract cancer that has been removed by surgery.

      PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride
      together with oxaliplatin to see how well it works compared with observation in treating
      patients with biliary tract cancer that has been removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare disease-free survival (DFS) of patients with resected biliary tract cancer
           treated with adjuvant gemcitabine hydrochloride and oxaliplatin versus clinical
           observation.

        -  Compare quality of life of these patients.

      Secondary

        -  Compare overall survival of these patients.

        -  Determine the toxicity of the chemotherapy in these patients.

        -  Explore prognostic factors for DFS including resection result (R0 vs R1), location of
           primary tumor (intrahepatic vs extrahepatic vs gallbladder), evolution of CA19-9, and
           lymph node involvement (N0 vs N+ and Nx). (Exploratory)

        -  Study pathological factors in surgical specimens to identify main characteristics and
           phenotypic clinicoanatomical biliary tract cancers before therapy. (Exploratory)

        -  Identify nontumor-associated liver injury and factors that may facilitate the emergence
           of biliary tract cancers. (Exploratory)

        -  Identify signaling pathways that may predict response to therapy. (Exploratory)

        -  Determine the molecular characteristics to differentiate tumors according to their
           position in the biliary tract (extrahepatic bile duct, intrahepatic cholangiocarcinoma
           site [hilar], and peripheral cholangiocarcinoma vesicle site). (Exploratory)

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and
           oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 12 courses.

        -  Arm II: Patients undergo clinical observation only every 4 weeks for 5 months. Quality
           of life is assessed at baseline, at 3 and 6 months, and then at all follow-up visits.

      After completion of study therapy, patients are followed up at 6 months, every 3 months for 2
      years, and then every 6 months for 3 years.
    

Intervention name(s): gemcitabine hydrochloride; oxaliplatin; clinical observation; adjuvant therapy; quality-of-life assessment
Intervention type(s): Drug; Drug; Other; Procedure; Procedure
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the extrahepatic bile duct; cholangiocarcinoma of the extrahepatic bile duct; liver and intrahepatic biliary tract cancer; localized extrahepatic bile duct cancer; adenocarcinoma of the gallbladder; cholangiocarcinoma of the gallbladder; localized gallbladder cancer