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:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT03779035
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed biliary tract cancer (including intrahepatic, extrahepatic, hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct)
* Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both
* Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete
* Must be able to start treatment within 12 weeks of surgery
* No pancreatic or periampullary cancer
* No mucosal gallbladder cancer
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Urea \< 1.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* Glomerular filtration rate ≥ 60 mL/min (if \< 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA)
* Hemoglobin ≥ 10 g/dL
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 3 times ULN
* ALT and AST ≤ 5 times ULN
* Adequate surgical biliary drainage with no evidence of infection
* Not pregnant or nursing
* Negative pregnancy test for women of childbearing age and childbearing potential
* Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended
* Must provide written informed consent
* No history of other malignant diseases within the past 5 years
* No serious coexisting medical condition likely to interfere with protocol treatment, including a potential serious infection
* No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
* No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance
* No other serious uncontrolled medical conditions
* No unresolved biliary tree obstruction
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Completely recovered from prior surgery
* No use of other investigational agents within 28 days prior to and during study treatment
* No prior chemotherapy or radiotherapy for biliary tract cancer
* No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03779035
Study Brief:
Protocol Section:
NCT03779035