Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

Study Overview
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Brief Summary
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In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy, along with one additional course of chemotherapy.

Detailed Description
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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)

Official Title
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Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

Conditions
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Esophagus Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Carboplatin
* Drug: 5-Fluorouracil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel|nan|
|Drug: Carboplatin|nan|
|Drug: 5-Fluorouracil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the toxicity of these two treatment approaches in localized esophageal cancer |  |  | 
| To evaluate the utility of clinical restaging in guiding local therapy (surgical resection vs definitive radiation therapy) following neo-adjuvant treatment |  |  | 
| To evaluate the toxicity of additional chemotherapy and radiation therapy following completion of neo-adjuvant treatment. |  |  |