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NCT04233866 · ClinicalTrials.gov registry record · Phase 2
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
A Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 176
- Enrollment target
- 20
- Study locations
NCT04233866: Active Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04233866 is a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8 that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 176 participants, above the 85-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04233866, a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 176 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, 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. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.
Primary Outcome
Will use a stratified log rank test with one-sided alpha of 0.05 and 90% power. A truncated O'Brien-Fleming boundary will be used to control type I error for efficacy testing and repeated confidence interval methodology on the OS hazard ratio will be used for futility analyses
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Gemcitabine
- DRUG Gemcitabine Hydrochloride
- DRUG Leucovorin Calcium
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mercy Cancer Center �� Carmichael - Carmichael
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2020-08-26 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04233866 still lists
NCT04233866 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, above the 85-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (107% higher).
The record links to 2 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT04233866 names 20 study sites across 5 states, led by Alaska, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04233866 about?
NCT04233866 is a clinical study titled "Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread". This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as ...
What is the current status of trial NCT04233866?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2020-08-26. Estimated completion is 2026-12-31.
What conditions does trial NCT04233866 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8.
What interventions are being tested in trial NCT04233866?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Gemcitabine (DRUG), Gemcitabine Hydrochloride (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT04233866?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04233866 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04233866's enrollment target sits among peer trials
176 4th of 37 higher than 34 of 37 other Metastatic Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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