Spots Global Cancer Trial Database for Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
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Trial Identification
Brief Title: Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
Official Title: Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
Study ID: NCT00193141
Conditions
Study Description
Brief 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)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: John D. Hainsworth, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
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