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

Conditions: Esophageal Cancer

Summary: 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.

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.

Eligibility criteria:
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

Keywords: stage iia esophageal cancer stage iib esophageal cancer stage iiia esophageal cancer stage iiib esophageal cancer stage iiic esophageal cancer stage iv esophageal cancer