S-1, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIA, Stage III, or Stage IVA Esophageal Cancer That Can Be Removed by Surgery

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy together with more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving S-1 and cisplatin together with radiation therapy works in treating patients with stage IIA, stage III, or stage IVA esophageal cancer that can be removed by surgery.

Detailed Description
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OBJECTIVES: Primary To evaluate response rate in patients with stage IIA-IVA resectable esophageal cancer treated with chemoradiotherapy comprising S-1, cisplatin, and radiotherapy. Secondary To evaluate overall survival of these patients. To evaluate progression-free survival of these patients. To evaluate toxicity in these patients. To correlate initial squamous cell carcinoma antigen and C-reactive protein with response and survival in these patients. OUTLINE: Patients receive oral S-1 twice weekly, cisplatin IV over 2 hours on day 1, and undergo radiotherapy 5 days a week in weeks 1 and 2. Treatment repeats every 3 weeks for 2 courses. Tumor tissue samples are collected by esophagoscopy with biopsy and brushings for analysis of initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival. After completion of study treatment, patients are followed for 6 months.

Official Title
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A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: tegafur-gimeracil-oteracil potassium
* Other: cytology specimen collection procedure
* Procedure: endoscopic biopsy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the esophagus Stage IIA-IVA disease Resectable disease Measurable disease, defined as at least 1 measurable lesion by RECIST criteria No known brain metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months ANC ≥ 1,500/uL Hemoglobin ≥ 9.0 g/dL (transfusion correction allowed) Platelets ≥ 100,000/uL Creatinine < 1.5 mg/dL Total bilirubin < 2 times upper limit of normal (ULN) ALT/AST < 3 times ULN Fertile patients must use effective contraception Not pregnant or nursing Able to take oral medication No active peptic ulcer disease No known hypersensitivity to study drugs No serious uncontrolled systemic intercurrent illness, including the following: Poorly controlled diabetes Active infection No history of significant neurological or mental disorder, including seizures or dementia No malignancy within the past 5 years, except carcinoma in situ of the cervix, or nonmelanomatous carcinoma of the skin No active cardiac disease uncontrolled by therapy No myocardial infarction within the past 12 months No interstitial lung disease or extended fibrosis of lung PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for esophageal cancer No prior surgical procedure affecting absorption No concurrent flucytosine or other fluoropyrimidine-group anticancer drugs No concurrent systemic chemotherapy, investigational drug, or radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: tegafur-gimeracil-oteracil potassium|nan|
|Other: cytology specimen collection procedure|nan|
|Procedure: endoscopic biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Progression-free survival |  |  | 
| Toxicity |  |  | 
| Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer