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| ID | Type | Description | Link |
|---|---|---|---|
| YONSEI-4-2007-0342 |
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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
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| tegafur-gimeracil-oteracil potassium | Drug | |||
| cytology specimen collection procedure | Other | |||
| endoscopic biopsy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Progression-free survival | ||
| Toxicity |
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DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the esophagus
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Joo-Hang Kim, MD | Yonsei University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cancer Center at Yonsei University Medical Center | Recruiting | Seoul | 120-752 | South Korea |
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| Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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