Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04539808
The ClinicalTrials.gov registry entry for NCT04539808 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The listed sponsor is OHSU Knight Cancer Institute, which has 211 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Pancreatic Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Multicenter Trial of ESK981 in Patients With Select Solid Tumors
RECRUITING · Phase 2
-
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
RECRUITING · Phase 2
-
Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)
RECRUITING · Phase 2
-
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
RECRUITING · Phase 2
-
9-ING-41 in Patients with Advanced Cancers
ACTIVE NOT RECRUITING · Phase 2
-
Pre-operative Treatment for Patients With Untreated Pancreatic Cancer
ACTIVE NOT RECRUITING · Phase 2
Explore more on PlainTrial
Pancreatic Adenocarcinoma
All registered trials for this condition
Stage III Pancreatic Cancer American Joint Committee on Cancer v8
All registered trials for this condition
Oregon
All trials with a study site in Oregon
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.