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
- Compare disease-free survival (DFS) of patients with resected biliary tract cancer
treated with adjuvant gemcitabine hydrochloride and oxaliplatin versus clinical
- Compare quality of life of these patients.
- 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.
Masking: Open Label, Primary Purpose: Treatment
Eveline Boucher, MD
Centre Eugene Marquis