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NCT04028167 · ClinicalTrials.gov registry record · Phase 2
Induction FLOT With CROSS CRT for Esophageal Cancer
A Phase 2 study of Adenocarcinoma of the Gastroesophageal Junction and Adenocarcinoma Esophagus, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 7
- Study locations
NCT04028167: Active Phase 2 study of Adenocarcinoma of the Gastroesophageal Junction and Adenocarcinoma Esophagus, sponsored by University of Colorado, Denver.
NCT04028167 is a Phase 2 study of Adenocarcinoma of the Gastroesophageal Junction and Adenocarcinoma Esophagus that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 40 participants, below the 87-participant average among 7 other Adenocarcinoma of the Gastroesophageal Junction trials with a reported enrollment target (54% lower). The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04028167, a Phase 2 study of Adenocarcinoma of the Gastroesophageal Junction and Adenocarcinoma Esophagus, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study evaluates a novel regimen of induction chemotherapy using a combination of docetaxel, oxaliplatin, and leucovorin, with short term infusional 5-FU (FLOT), given prior to chemoradiotherapy with concurrent carboplatin and paclitaxel, as neoadjuvant therapy prior to definitive surgical resection for patients with adenocarcinoma of the esophagus or gastroesophageal junction
Primary Outcome
The percentage of pathologic complete response at resection for patients who has completed the study regimen of induction FLOT, CROSS regimen chemoradiation, and surgical resection
Conditions Studied
Interventions
- DRUG Sequential FLOT followed by chemoradiation
Study Locations (7)
Colorado
- University of Colorado Hospital - Aurora
- UCHealth Southern Colorado - Memorial Hospital Central - Colorado Springs
- UCHealth Southern Colorado - Memorial Hospital North - Colorado Springs
- UCHealth Northern Colorado - Poudre Valley Hospital - Fort Collins
- UCHealth Northern Colorado - Harmony Campus - Fort Collins
- UCHealth Northern Colorado - Greeley Hospital - Greeley
- UCHealth Northern Colorado Medical Center of the Rockies - Loveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-04-08 |
| Est. Completion | 2027-04-19 |
| Phase | Phase 2 |
What the registry record for NCT04028167 still lists
NCT04028167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 87-participant average among 7 other Adenocarcinoma of the Gastroesophageal Junction trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Adenocarcinoma of the Gastroesophageal Junction appearing as the primary indexed condition, and to 1 intervention - of which Sequential FLOT followed by chemoradiation is the first listed.
NCT04028167 lists 7 locations in 1 state (Colorado).
Frequently Asked Questions
What is clinical trial NCT04028167 about?
NCT04028167 is a clinical study titled "Induction FLOT With CROSS CRT for Esophageal Cancer". This study evaluates a novel regimen of induction chemotherapy using a combination of docetaxel, oxaliplatin, and leucovorin, with short term infusional 5-FU (FLOT), given prior to chemoradiotherapy with concurrent carboplatin and paclitaxel, as neoadjuvant therapy prior to definitive surgical resec...
What is the current status of trial NCT04028167?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-04-08. Estimated completion is 2027-04-19.
What conditions does trial NCT04028167 study?
This clinical trial studies the following conditions: Adenocarcinoma of the Gastroesophageal Junction, Adenocarcinoma Esophagus.
What interventions are being tested in trial NCT04028167?
The interventions under investigation include: Sequential FLOT followed by chemoradiation (DRUG).
Who is sponsoring clinical trial NCT04028167?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04028167 being conducted?
This trial has 7 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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