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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 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 59 participants.

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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.

Interventions

  • DRUG Docetaxel
  • DRUG Capecitabine
  • DRUG Oxaliplatin
  • RADIATION Radiation therapy

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2004-04
Est. Completion 2009-01
Phase Phase 1

Sponsor

SCRI Development Innovations

146 total trials

What the Registry Record Tells You About NCT00193128

The ClinicalTrials.gov registry entry for NCT00193128 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.

NCT00193128 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.