Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

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)

Inclusion criteria

To be included in this study, you must meet the following criteria:

• Cancer of the esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
• Received no previous treatment for esophageal cancer.
• Measurable or evaluable disease
• Able to perform activities of daily living with minimal assistance
• Adequate bone marrow, liver and kidney function
• Be at least 3 weeks from any major surgical procedures.
• Have an indwelling central venous access catheter.
• Patients must be able to understand the nature consent of the study and give written informed consent.

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

• Age < 18 years
• History of a prior malignancy within the past 5 years
• History of significant heart disease
• Inoperable on the basis of co-existent medical problems

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.