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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659113
Recruitment Status : Unknown
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 16, 2008
Last Update Posted : December 6, 2011
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: cisplatin Drug: tegafur-gimeracil-oteracil potassium Other: cytology specimen collection procedure Procedure: endoscopic biopsy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer
Study Start Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Overall survival
  2. Progression-free survival
  3. Toxicity
  4. Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659113

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Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joo-Hang Kim, MD    82-2-2228-8131   
Sponsors and Collaborators
Yonsei University
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Study Chair: Joo-Hang Kim, MD Yonsei University

Layout table for additonal information Identifier: NCT00659113     History of Changes
Other Study ID Numbers: CDR0000593402
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2008
Keywords provided by National Cancer Institute (NCI):
stage IIA esophageal cancer
stage IIB esophageal cancer
stage IIIA esophageal cancer
stage IIIB esophageal cancer
stage IIIC esophageal cancer
stage IV esophageal cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action