Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT00789958
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00789958
Study Brief:
Protocol Section:
NCT00789958