Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

Esophagus Cancer Clinical Trial

Official title: Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

Status Completed

Clinical Trial 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.

Clinical Trial Description

Upon determination of eligibility, all patients will receive neo-adjuvant therapy with:

Paclitaxel + Carboplatin + 5-Fluorouracil + Radiation

After neo-adjuvant therapy and restaging are completed, patients will be randomized to receive one of two treatments:

• Surgical resection (Arm A)

• Paclitaxel + Carboplatin + Radiation (Arm B) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

• NCT number: NCT00193141
• Study type: Interventional
• Source: SCRI Development Innovations, LLC
• Status: Completed
• Phase: Phase 2
• Start date: October 1999
• Completion date: July 2007