NCT01313377

Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Liver Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	oxaliplatin
OTHER	clinical observation
PROCEDURE	adjuvant therapy
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2009-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2011-03-11
• Last updated: 2017-01-25

Locations

37 sites across 1 country: France