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NCT04361708 · ClinicalTrials.gov registry record · Phase 1
Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
A Phase 1 study of Pancreatic Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT04361708: Recruiting Phase 1 study of Pancreatic Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by University of Chicago.
NCT04361708 is a Phase 1 study of Pancreatic Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 54 participants, below the 99,464-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
NCT04361708, a Phase 1 study of Pancreatic Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well).
Primary Outcome
To determine the maximum tolerated dose in the first month of therapy in each of the three main genotype groups (low, intermediate, and high risk) using genotype-guided dosing of irinotecan as part of the I-FLOAT regimen
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG 5-Fluorouracil
Study Locations (1)
Illinois
- The University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-05-08 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT04361708 shows while recruiting
NCT04361708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT04361708 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04361708 about?
NCT04361708 is a clinical study titled "Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies". The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well).
What is the current status of trial NCT04361708?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2020-05-08. Estimated completion is 2027-05.
What conditions does trial NCT04361708 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Adenocarcinoma.
What interventions are being tested in trial NCT04361708?
The interventions under investigation include: Docetaxel (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT04361708?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04361708 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04361708's enrollment target sits among peer trials
54 34th of 62 higher than 29 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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