Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title: A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer

Status Completed

Clinical Trial Summary

There is a need for more effective therapy for patients following surgery for esophageal carcinoma. Docetaxel and Irinotecan, independent of each other, have demonstrated activity in this disease. There is interest in the combination of these two active agents plus radiotherapy.

Clinical Trial Description

The high rate of local and distant failure following surgery for esophageal carcinoma necessitates a more effective therapy for these patients. The merit of neoadjuvant chemotherapy is early management of micrometastatic disease and radiosensitization. A longstanding regimen, 5-FU and Cisplatin, have failed to produce a substantial survival benefit, but the approach has resulted in pathologic complete responses prior to surgical eradication of the diseased organ. This raises questions of organ preservation in some patients. Docetaxel and Irinotecan have both demonstrated independent activity in this disease and are radiosensitizers. In this study, Docetaxel and Irinotecan will be given together weekly for 3 consecutive weeks in an attempt to decrease the recurrence of systemic disease, and this will be followed by giving each agent independently with radiation therapy to decrease the local relapse rate and independently measure the toxicity of each with radiation. Following completion of chemoradiotherapy, the patients will undergo resection and be evaluated for the pathologic response rate. ;

Related Conditions & MeSH terms

• Cancer of Esophagus
• Cancer of the Esophagus
• Esophageal Cancer
• Esophageal Neoplasm
• Esophageal Neoplasms
• Esophagus Cancer

• NCT number: NCT00318903
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Completed
• Phase: Phase 2
• Start date: January 2002
• Completion date: April 2006