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NCT02047474 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer
A Phase 2 study of Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 9
- Study locations
NCT02047474: Completed Phase 2 study of Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, sponsored by Yale University.
NCT02047474 is a Phase 2 study of Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas that has completed, run by Yale University. The registered enrollment target is 46 participants, below the 54-participant average among 3 other Acinar Cell Adenocarcinoma of the Pancreas trials with a reported enrollment target (15% lower). The trial reports 9 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02047474, a Phase 2 study of Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 9
- Study locations
Study Summary
This phase II trial studies how well combination chemotherapy before and after surgery works in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Primary Outcome
Evaluated using a one-sided 0.10-alpha level exact test. Summarized using Kaplan-Meier curves
Conditions Studied
Interventions
- DRUG oxaliplatin
- PROCEDURE therapeutic conventional surgery
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG irinotecan hydrochloride
Study Locations (9)
Connecticut
- Smilow Cancer Hospital at Fairfield - Fairfield
- Smilow Cancer Hospital at Guilford - Guilford
- Smilow Cancer Hospital at St. Francis Hospital - Hartford
- Yale University - New Haven
- Smilow Cancer Hospital at North Haven - North Haven
- Smilow Cancer Hospital at Orange - Orange
- Smilow Cancer Hospital at Torrington - Torrington
- Smilow Cancer Hospital at Trumbull - Trumbull
- Smilow Cancer Hospital at Waterbury - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-03-25 |
| Est. Completion | 2024-01-14 |
| Phase | Phase 2 |
What the finished NCT02047474 record still lists
NCT02047474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 54-participant average among 3 other Acinar Cell Adenocarcinoma of the Pancreas trials with a reported enrollment target (15% lower).
The record links to 5 conditions, with Acinar Cell Adenocarcinoma of the Pancreas appearing as the primary indexed condition, and to 5 interventions - of which oxaliplatin is the first listed.
NCT02047474 lists 9 locations in 1 state (Connecticut).
Frequently Asked Questions
What is clinical trial NCT02047474 about?
NCT02047474 is a clinical study titled "Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer". This phase II trial studies how well combination chemotherapy before and after surgery works in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the grow...
What is the current status of trial NCT02047474?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2014-03-25. Estimated completion is 2024-01-14.
What conditions does trial NCT02047474 study?
This clinical trial studies the following conditions: Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage I Pancreatic Cancer.
What interventions are being tested in trial NCT02047474?
The interventions under investigation include: oxaliplatin (DRUG), therapeutic conventional surgery (PROCEDURE), fluorouracil (DRUG), leucovorin calcium (DRUG), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02047474?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02047474 being conducted?
This trial has 9 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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