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
18 Years
N/A
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival
Safety Issue:
No
Principal Investigator
Eveline Boucher, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Eugene Marquis
Authority:
Unspecified
Study ID:
CDR0000696193
NCT ID:
NCT01313377
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
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