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NCT03768414 · ClinicalTrials.gov registry record · Phase 3
Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 452
- Enrollment target
NCT03768414: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT03768414 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 452 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03768414, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 452 participants
- Enrollment target
Study 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.
Primary Outcome
OS will be determined using the log-rank test with stratification by disease site (gallbladder adenocarcinoma versus \[vs.\] intrahepatic cholangiocarcinoma vs. extrahepatic cholangiocarcinoma), disease stage (locally advanced vs. metastatic), and Zubrod performance status (0 vs. 1). Distributions of overall survival by treatment arm will be estimated using the method of Kaplan-Meier.
Interventions
- DRUG Cisplatin
- DRUG Nab-paclitaxel
- DRUG Gemcitabine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2019-02-07 |
| Est. Completion | 2024-10-28 |
| Phase | Phase 3 |
What the finished NCT03768414 record still lists
NCT03768414 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT03768414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03768414 about?
NCT03768414 is a clinical study titled "Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers". 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, cisplat...
What is the current status of trial NCT03768414?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 452 participants. The study started on 2019-02-07. Estimated completion is 2024-10-28.
What interventions are being tested in trial NCT03768414?
The interventions under investigation include: Cisplatin (DRUG), Nab-paclitaxel (DRUG), Gemcitabine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03768414?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03768414's enrollment target sits among peer trials
452 835th of 2000 higher than 1,165 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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