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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

Phase 3
18 Years
Open (Enrolling)
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

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Trial Information

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.

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:


Principal Investigator

Eveline Boucher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Eugene Marquis



Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • 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
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Biliary Tract Neoplasms