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Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

NCT00193141 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-05-03

No results posted yet for this study

Summary

In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy, along with one additional course of chemotherapy.

Conditions

  • Esophagus Cancer

Interventions

DRUG

Paclitaxel

DRUG

Carboplatin

DRUG

5-Fluorouracil

Sponsors & Collaborators

Principal Investigators

  • John D. Hainsworth, MD · SCRI Development Innovations, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2004-10-31
Completion
2007-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193141 on ClinicalTrials.gov