We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00659113
First Posted: April 16, 2008
Last Update Posted: December 6, 2011
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Overall survival
  • Progression-free survival
  • Toxicity
  • Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival

Estimated Enrollment: 32
Study Start Date: March 2008
Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00659113


Locations
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    kjhang@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Joo-Hang Kim, MD Yonsei University
  More Information

ClinicalTrials.gov Identifier: NCT00659113     History of Changes
Other Study ID Numbers: CDR0000593402
YONSEI-4-2007-0342
First Submitted: April 15, 2008
First Posted: April 16, 2008
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:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Tegafur
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action