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NCT00193128 · ClinicalTrials.gov registry record · Phase 1
Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT00193128: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT00193128 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00193128, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Primary Outcome
The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response
Interventions
- DRUG Docetaxel
- DRUG Capecitabine
- DRUG Oxaliplatin
- RADIATION Radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2004-04 |
| Est. Completion | 2009-01 |
| Phase | Phase 1 |
What the finished NCT00193128 record still lists
NCT00193128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT00193128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00193128 about?
NCT00193128 is a clinical study titled "Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer". In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drug...
What is the current status of trial NCT00193128?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2004-04. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00193128?
The interventions under investigation include: Docetaxel (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), Radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00193128?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00193128's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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