NCT00659113Unknown2 期
A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Response rate
次要结局
- Overall survival
- Progression-free survival
- Toxicity
- Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival
研究者
研究点 (1)
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