Phase II Trial of Preoperative Combined Modality Therapy for Localized Esophageal Carcinoma: Cisplatin-Paclitaxel Followed by Radiation Therapy With Concurrent Cisplatin and Paclitaxel
OBJECTIVES: I. Determine the response rate to preoperative induction paclitaxel/cisplatin
followed by concurrent paclitaxel/cisplatin and radiotherapy in locally advanced esophageal
cancer. II. Determine the toxic effects, including surgical morbidity and mortality, and
patient survival after this combination therapy. III. Monitor the quality of life of
patients receiving this combination therapy. IV. Determine c Jun oncogene and thymidylate
synthase expression and p53 mutation before and after this combination therapy.
OUTLINE: This is an open label, multicenter study. (Adenocarcinoma stratum closed) Patients
receive of induction chemotherapy consisting of paclitaxel IV over 3 hours followed by
cisplatin IV on days 1 and 22. Patients then receive radiation therapy 5 days a week for 6
weeks, along with paclitaxel and cisplatin 4 days a week. Patients undergo surgery (complete
or partial resection) within 4-8 weeks of completion of the chemoradiotherapy. Patients are
followed every 3 months for the first 2 years, every 6 months for the next 2 years, and
annually thereafter. Quality of life is assessed for the first year of follow up only.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for each histology
(adenocarcinoma, squamous carcinoma) within 18-24 months. (Adenocarcinoma stratum closed)
Interventional
Primary Purpose: Treatment
David H. Ilson, MD, PhD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
97-088
NCT00003087
August 1997
February 2005
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |