Liver Cancer Clinical Trial
Official title:
Phase III Multicenter Randomized Study Comparing the Effect of Adjuvant Chemotherapy for Six Months With Gemcitabine-Oxaliplatin 85 mg/m2 (GEMOX 85) to Observation in Patients Who Underwent Surgery for Cancer of the Bile Ducts
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.
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.
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