Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma

Study Summary

The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared. Objectives: Primary objective: Compare the Pathologic Complete Response rate and % of patients with \<50% residual cancer in the resected surgical specimen between Arms A and B. Secondary objectives: 1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B 2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome. 3. Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.

Primary Outcome

Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) \<50% of residual cells in the surgical specimen; or 3) \>50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately

Interventions

• DRUG Oxaliplatin
• RADIATION Radiation Therapy
• DRUG 5-Fluorouracil
• PROCEDURE Surgery