Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With … (NCT03768414) | Clinical Trial Compass
CompletedPhase 3
Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
United States452 participantsStarted 2019-02-07
Plain-language summary
This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, 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. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
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:
* Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer
* NOTE: Pathology report must be uploaded in Rave. Histology report must be consistent with an adenocarcinoma with pancreaticobiliary primary assuming there are no pancreatic lesions and other primaries are ruled out per local standard
* Patients must have documented metastatic or locally advanced unresectable disease on computed tomography (CT) or magnetic resonance (MR) imaging CT scans or MRIs used to assess measurable disease. Must have been completed within 28 days prior to registration. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
* Patient must not have a current diagnosis of ampullary cancer
* Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer
* Patient must not have received adjuvant therapy within 6 months prior to registration
* Patients must have a complete medical history and physical exam within 28 days prior to registration
* Patients must have a Zubrod performance status of 0 or 1
* Patients must not have a history of peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. In CTCAE version 5.0 grade 2 sensory neuropathy i…
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.
1This trial compared gemcitabine plus cisplatin alone against the same combination with nab-paclitaxel added — based on the results, did adding nab-paclitaxel actually improve survival for patients with my type of biliary tract cancer, and would that finding apply to my specific situation?
2Since this is a completed Phase 3 trial measuring overall survival, has the final data been published, and can you walk me through what the survival numbers actually showed so I can understand what the realistic benefit or difference might look like?
3The trial included several different cancer types — cholangiocarcinoma, gallbladder cancer, and bile duct cancer — so do the results hold up equally across all of them, or did patients with my specific diagnosis respond differently to the three-drug regimen?
4Adding nab-paclitaxel to an already intensive chemotherapy regimen likely means more side effects — based on the trial data, what kinds of additional toxicities were reported, and how would you weigh those risks against any survival benefit for someone in my condition?
5Given that this trial is now completed and the data exists, is the three-drug combination with nab-paclitaxel something you'd consider as a standard treatment option for me, or would you recommend starting with the standard gemcitabine and cisplatin doublet first?
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.