Status:
COMPLETED
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ra...
Detailed Description
OBJECTIVES: * To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy comprising cap...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00789958
Start Date
December 1 2008
End Date
December 1 2017
Last Update
April 9 2018
Active Locations (251)
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1
Regional Medical Center
Anniston, Alabama, United States, 36207
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
4
Peninsula Medical Center
Burlingame, California, United States, 94010