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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT03579758
Eligibility Criteria:
Inclusion Criteria:
* Histologically-confirmed T1b, T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease
* Resectable disease at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the chest, abdomen, and pelvis (C/A/P)
* Enrollment and randomization within 12 weeks of initial cholecystectomy
* High-quality cross-sectional imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) performed within 4 weeks prior to enrollment
* Able to give informed consent
* Able to adhere to study visit schedule and other protocol requirements
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 2
* Absolute neutrophil count ≥ 1500/mm³
* Platelet count ≥ 100,000/mm³
Exclusion Criteria:
* Patients with histologically-confirmed Tis, T1a, or T4 tumors
* Unresectable gallbladder cancer at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the C/A/P
* Unable to sign informed consent
* Serum creatinine \> 1.5 x upper limit of normal or estimated creatinine clearance (CrCl) \< 45 ml/min
* Serum total bilirubin \> 1.5 x upper limit of normal
* Presence of active infection
* Pregnant and/or breastfeeding
* Known dihydropyrimidine dehydrogenase deficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03579758
Study Brief:
Protocol Section:
NCT03579758