Status:
UNKNOWN
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
Lead Sponsor:
Yonsei University
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 the...
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 * ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00659113
Start Date
March 1 2008
Last Update
December 6 2011
Active Locations (1)
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1
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea, 120-752