Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery
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.
Extrahepatic Bile Duct Cancer
Drug: gemcitabine hydrochloride
Other: clinical observation
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Disease-free survival [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity of adjuvant chemotherapy [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Hopital Saint Antoine||Recruiting|
|Paris, France, 75571|
|Contact: Contact Person 33-1-4928-2345 email@example.com|
|Centre Eugene Marquis||Recruiting|
|Rennes, France, 35042|
|Contact: Contact Person 33-2-9925-3180 firstname.lastname@example.org|
|CHU Sainte-Etienne - Hopital Nord||Recruiting|
|Sainte-Etienne, France, 42255|
|Contact: Contact Person 33-4-7782-8320 email@example.com|
|Principal Investigator:||Eveline Boucher, MD||Centre Eugene Marquis|