COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313377
Recruitment Status : Completed
First Posted : March 11, 2011
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Drug: gemcitabine hydrochloride Drug: oxaliplatin Other: clinical observation Procedure: adjuvant therapy Procedure: quality-of-life assessment Phase 3

Detailed Description:



  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: ARM A: Gemox 85
Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)
Drug: gemcitabine hydrochloride
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Observation until progression or death
Other: clinical observation
Procedure: quality-of-life assessment

Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: up to 3 years ]
  2. Quality of life [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]
  2. Toxicity of adjuvant chemotherapy [ Time Frame: up to 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven adenocarcinoma of the intrahepatic bile ducts, gallbladder, or extrahepatic bile ducts

    • Mixed forms of hepatocholangiocarcinomas included provided the cholangiocarcinoma is predominant
  • Underwent surgical resection of the disease (R0 or R1) at least 4 weeks but no more than 13 weeks ago
  • Nonmetastatic disease as assessed by abdominal MRI and chest x-ray
  • No cancer of the pancreas or duodenum invading the bile duct and ampulla of Vater


  • ECOG performance status 0-2
  • Hemoglobin ≥ 10 g/dL (transfusion allowed)
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Creatinine clearance > 40 mL/min
  • Prothrombin time > 60% OR INR < 1.5 (without anticoagulant therapy)
  • Transaminases ≤ 5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Conjugated bilirubin ≤ 35 μmol/L (after biliary drainage, if necessary)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications to oxaliplatin and gemcitabine hydrochloride therapy
  • Prior invasive cancer allowed provided it has been in complete remission for ≥ 5 years
  • No other concurrent invasive cancer except adequately treated carcinoma in situ of the cervix or basal cell carcinoma
  • No other severe, unresolved disease
  • No mental illness
  • No HIV positivity
  • No grade 1 angina or symptomatic angina ≥ grade 2
  • No sensitive peripheral neuropathy
  • No uncontrolled diabetes
  • No inability to undergo medical tests due to geographical, social, or psychological reasons
  • No prisoners or patients under guardianship
  • No Child B or C cirrhosis


  • See Disease Characteristics
  • No prior neoadjuvant chemotherapy or radiotherapy
  • No prior organ transplantation
  • No concurrent participation in another clinical trial of an experimental agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01313377

Show Show 37 study locations
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Eveline Boucher, MD Centre Eugene Marquis
Layout table for additonal information
Responsible Party: UNICANCER Identifier: NCT01313377    
Other Study ID Numbers: CDR0000696193
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Keywords provided by UNICANCER:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Gallbladder Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs