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Brief Title: Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
Official Title: A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction
Study ID: NCT00193128
Brief Summary: In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Detailed Description: Upon determination of eligibility, patients will be receive: Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tower Oncology, Beverly Hills, California, United States
Integrated Community Oncology Network, Jacksonville, Florida, United States
Atlanta Cancer Care, Atlanta, Georgia, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Wellstar Cancer Research, Marietta, Georgia, United States
Consultants in Blood Disorders and Cancer, Louisville, Kentucky, United States
Tennessee Oncology, Nashville, Tennessee, United States
Name: David R. Spigel, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR