A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or
bile duct, meeting at least 1 of the following criteria:

- Pathological T2-4 disease

- Pathological N1 disease

- Positive margins (any T or N )

- Must have undergone potentially curative radical resection with negative (R0) or
microscopically positive (R1) margins within the past 56 days and recovered (R0
stratum closed as of 12-15-11)

- No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen,
and pelvis within the past 42 days

- Positive resected regional lymph nodes allowed

- No ampullary cancer

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- ANC > 1,500/μL

- Platelet count > 100,000/μL

- Serum creatinine < 1.5 mg/dL

- Total bilirubin < 1.5 times upper limit of normal (ULN)

- SGOT or SGPT < 2.5 times ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to swallow enteral medications and no requirement for a feeding tube

- No intractable nausea or vomiting

- No gastrointestinal (GI) tract disease resulting in an inability to take oral
medication, malabsorption syndrome, requirement for IV alimentation, prior surgical
procedures affecting absorptions. or uncontrolled inflammatory GI disease (e.g.,
Crohn disease, ulcerative colitis)

- No uncontrolled intercurrent illness including but not limited to any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Myocardial infarction or cerebrovascular accident within the past 3 months

- Uncontrolled diarrhea

- Psychiatric illness or social situations that would limit compliance with study
requirements

- No prior malignancy except for adequately treated basal cell (or squamous cell) skin
cancer, in situ cervical cancer, or other cancer from which the patient has been
disease-free for 5 years

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or radiotherapy for this disease

- No prior upper abdominal radiotherapy