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NCT04097028 · ClinicalTrials.gov registry record · Phase 2
Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT04097028: Completed Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT04097028 is a Phase 2 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04097028, a Phase 2 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
This phase II trial studies how well trifluridine/tipiracil and oxaliplatin work as the first line of treatment (induction) in treating patients with esophageal or gastroesophageal junction adenocarcinoma that can be removed by surgery (resectable). Drugs used in chemotherapy, such as trifluridine/tipiracil and oxaliplatin, 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.
Primary Outcome
Will be determined by pathologic examination of resected specimen: complete response to induction chemotherapy followed by standard chemoradiation and surgery. Will be summarized using frequencies and relative frequencies. Will be estimated using an 80% confidence interval obtained using Jeffrey's prior method. Response is assessed by the tumor regression score (as proposed by NCCN guidelines): Complete Response: No viable cancer cells, including lymph nodes Near Complete Response: Single cell
Interventions
- DRUG Oxaliplatin
- DRUG Trifluridine and Tipiracil Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2025-02-05 |
| Phase | Phase 2 |
What the finished NCT04097028 record still lists
NCT04097028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxaliplatin is the first listed.
NCT04097028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04097028 about?
NCT04097028 is a clinical study titled "Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma". This phase II trial studies how well trifluridine/tipiracil and oxaliplatin work as the first line of treatment (induction) in treating patients with esophageal or gastroesophageal junction adenocarcinoma that can be removed by surgery (resectable). Drugs used in chemotherapy, such as trifluridine/t...
What is the current status of trial NCT04097028?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2019-12-20. Estimated completion is 2025-02-05.
What interventions are being tested in trial NCT04097028?
The interventions under investigation include: Oxaliplatin (DRUG), Trifluridine and Tipiracil Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04097028?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04097028's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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