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NCT02178709 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Neoadjuvant FOLFIRINOX
A Phase 2 study of Resectable Pancreatic Ductal Adenocarcinoma, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT02178709: Completed Phase 2 study of Resectable Pancreatic Ductal Adenocarcinoma, sponsored by Indiana University.
NCT02178709 is a Phase 2 study of Resectable Pancreatic Ductal Adenocarcinoma that has completed, run by Indiana University. The registered enrollment target is 48 participants, below the 86-participant average among 5 other Resectable Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02178709, a Phase 2 study of Resectable Pancreatic Ductal Adenocarcinoma, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue collection component.
Primary Outcome
Pathologic complete response was evaluated using MRI or CT and Evan's criteria for pathologic response following neoadjuvant therapy: I: \<10% to no tumor cells destroyed IIa: 10-50% of tumor cells destroyed IIb: 50-90% of tumor cells destroyed III: \>90% of tumor cells destroyed IIIM: sizable pools of cellular mucin IV: No viable tumor cells (complete pathologic response) IVM: Acellular pools of mucin
Conditions Studied
Interventions
- DRUG FOLFIRINOX
Study Locations (1)
Indiana
- Indiana University Simon Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-06-03 |
| Est. Completion | 2019-10-28 |
| Phase | Phase 2 |
What the finished NCT02178709 record still lists
NCT02178709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 86-participant average among 5 other Resectable Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Resectable Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which FOLFIRINOX is the first listed.
NCT02178709 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT02178709 about?
NCT02178709 is a clinical study titled "A Phase II Study of Neoadjuvant FOLFIRINOX". The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue collection component.
What is the current status of trial NCT02178709?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2014-06-03. Estimated completion is 2019-10-28.
What conditions does trial NCT02178709 study?
This clinical trial studies the following conditions: Resectable Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT02178709?
The interventions under investigation include: FOLFIRINOX (DRUG).
Who is sponsoring clinical trial NCT02178709?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02178709 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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