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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Cisplatin; Tegafur

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