Spots Global Cancer Trial Database for Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
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Trial Identification
Brief Title: Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
Official Title: A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer
Study ID: NCT00393068
Conditions
Study Description
Brief Summary: The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer. Side effects (toxicity) information will also be collected.
Detailed Description: Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery. Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks). Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Florida Cancer Specialists, Fort Myers, Florida, United States
Integrated Community Oncology Network, Jacksonville, Florida, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Consultants in Blood Disorders and Cancer, Louisville, Kentucky, United States
Hematology Oncology Associates of Northern NJ, Morristown, New Jersey, United States
Aultman Hospital, Canton, Ohio, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Contact Details
Name: John D Hainsworth, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
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