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

April 15, 2008
December 3, 2011
March 2008
Not Provided
Response rate [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00659113 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: cisplatin
  • Drug: tegafur-gimeracil-oteracil potassium
  • Other: cytology specimen collection procedure
  • Procedure: endoscopic biopsy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
Not Provided
Not Provided

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
Both
18 Years to 75 Years
No
Not Provided
Korea, Republic of
 
NCT00659113
CDR0000593402, YONSEI-4-2007-0342
Not Provided
Not Provided
Yonsei University
Not Provided
Study Chair: Joo-Hang Kim, MD Yonsei University
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP