Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer (NCT03579758) | Clinical Trial Compass
WithdrawnPhase 3
Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer
Stopped: This trial will open as an NCTN trial.
United States0Started 2019-04-03
Plain-language summary
This phase III trial studies how well chemotherapy before and after surgery works in treating participants with gallbladder cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin, gemcitabine, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery may kill more tumor cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.