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
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: 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
Study Type
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Name: cisplatin Type: Drug
Name: tegafur-gimeracil-oteracil potassium Type: Drug
Name: cytology specimen collection procedure Type: Other
Name: endoscopic biopsy Type: Procedure
Overall Status
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


- To evaluate response rate in patients with stage IIA-IVA resectable esophageal cancer treated with chemoradiotherapy comprising S-1, cisplatin, and radiotherapy.


- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both

- 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


- 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


- 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
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hang Kim, MD - 82-2-2228-8131 - kjhang@yuhs.ac
Start Date
March 2008
Yonsei University
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page