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NCT04539808 · ClinicalTrials.gov registry record · Phase 2
NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
A Phase 2 study of Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer American Joint Committee on Cancer v8, sponsored by OHSU Knight Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT04539808: Active Phase 2 study of Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer American Joint Committee on Cancer v8, sponsored by OHSU Knight Cancer Institute.
NCT04539808 is a Phase 2 study of Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer American Joint Committee on Cancer v8 that is active but no longer recruiting, run by OHSU Knight Cancer Institute. The registered enrollment target is 42 participants, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04539808, a Phase 2 study of Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer American Joint Committee on Cancer v8, is active but no longer recruiting, sponsored by OHSU Knight Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, 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. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.
Primary Outcome
Using the surgery analysis set, the proportion of resectable or BRPC participants with R0 resection will be estimated with exact 95% CI.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- DRUG Irinotecan Hydrochloride
- DRUG Leucovorin Calcium
- DRUG Losartan Potassium
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-05-27 |
| Est. Completion | 2027-01-05 |
| Phase | Phase 2 |
What the registry record for NCT04539808 still lists
NCT04539808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT04539808 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT04539808 about?
NCT04539808 is a clinical study titled "NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer". This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically...
What is the current status of trial NCT04539808?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2021-05-27. Estimated completion is 2027-01-05.
What conditions does trial NCT04539808 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer American Joint Committee on Cancer v8, Stage 0 Pancreatic Cancer American Joint Committee on Cancer v8, Stage I Pancreatic Cancer American Joint Committee on Cancer v8, Stage IV Pancreatic Cancer American Joint Committee on Cancer v8.
What interventions are being tested in trial NCT04539808?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Irinotecan Hydrochloride (DRUG), Leucovorin Calcium (DRUG), Losartan Potassium (DRUG).
Who is sponsoring clinical trial NCT04539808?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04539808 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04539808's enrollment target sits among peer trials
42 40th of 62 higher than 23 of 62 other Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Adenocarcinoma 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.
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