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

Yonsei University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Drug: tegafur-gimeracil-oteracil potassium; Drug: cisplatin; Procedure: endoscopic biopsy; Other: cytology specimen collection procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT00659113

CDR0000593402

YONSEI-4-2007-0342

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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