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
Conditions
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
Interventional
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
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
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
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
Sponsors
Yonsei University
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page