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NCT01661088 · ClinicalTrials.gov registry record · Phase 2
A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01661088: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT01661088 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01661088, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to address local disease, will achieve a significant improvement R0 resection (Radiation oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and enhance disease free and overall survival in this patient population.
Primary Outcome
To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Interventions
- DRUG FOLFIRINOX
- RADIATION Intensity-modulated radiotherapy (IMRT)
- PROCEDURE Surgical Exploration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-06 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 2 |
What the finished NCT01661088 record still lists
NCT01661088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which FOLFIRINOX is the first listed.
NCT01661088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01661088 about?
NCT01661088 is a clinical study titled "A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients". The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to address local disease, will...
What is the current status of trial NCT01661088?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-06. Estimated completion is 2019-08-30.
What interventions are being tested in trial NCT01661088?
The interventions under investigation include: FOLFIRINOX (DRUG), Intensity-modulated radiotherapy (IMRT) (RADIATION), Surgical Exploration (PROCEDURE).
Who is sponsoring clinical trial NCT01661088?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01661088's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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