A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The determination of pathologic response in patients who undergo surgical resection.
Approximately 14 weeks before eligible patients have surgery
James A. Posey, M.D.
University of Alabama at Birmingham
United States: Institutional Review Board
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|