NCT00193141

Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel
DRUG	Carboplatin
DRUG	5-Fluorouracil

Timeline

• Start date: 1999-10-01
• Primary completion: 2004-10-01
• Completion: 2007-07-01
• First posted: 2005-09-19
• Last updated: 2011-05-03