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 because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00659113
First received: April 15, 2008
Last updated: December 3, 2011
Last verified: December 2008
  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: 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00659113     History of Changes
Other Study ID Numbers: CDR0000593402, YONSEI-4-2007-0342
Study First Received: April 15, 2008
Last Updated: December 3, 2011
Health Authority: Unspecified

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014