Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma
Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. The purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma|
- To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.
- To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
- To assess the qualitative and quantitative toxicities of this regimen.
|Study Start Date:||November 1997|
|Study Completion Date:||July 2008|
|Primary Completion Date:||December 1999 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230451
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48197|
|Principal Investigator:||Susan Urba, M.D.||University of Michigan Cancer Center|