NCT03366883Unknown3 期
A Phase III Trial Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy With Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2018年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven squamous cell carcinoma.
- •All lesions are located in the thoracic esophagus.
- •Clinical stages IIB and III (excluding T4) based on the 7th UICC-TNM classification.
- •20-75 years old.
- •ECOG performance status of 0 or
- •Measurable lesions not required.
- •No prior therapy against esophageal cancer except for complete resection by endoscopic mucosal resection/endoscopic submucosal dissection with either pM1/M2 disease or pM3 disease without vascular infiltration.
- •No prior chemotherapy, radiotherapy or hormonal therapy against any cancers
- •Adequate organ function.
- •Written informed consent.
排除标准
- •Synchronous or metachronous double cancers, except for intramucosal tumor curatively resected by local therapy.
- •Active infection requiring systemic therapy
- •Positive hepatitis B surface antigen and hepatitis B core antigen or human immunodeficiency virus antibody.(only positive hepatitis B surface antigen should receive anti-virus treatment during study)
- •Pregnant or lactating women or women of childbearing potential.
- •Patients requiring systemic steroid medication.
- •Iodine hypersensitivity.
- •Psychiatric disease.
- •Hypersensitivity for CremophorEL.
- •Poorly controlled diabetes.
- •Severe emphysema or pulmonary fibrosis.
- •Poorly controlled hypertension.
- •Unstable angina within 3 weeks or with a history of myocardial infarction within 6 months.
结局指标
主要结局
Overall Survival
时间窗: 3 years
次要结局
- Rate of R0 resection(up to 24 weeks)
- Disease Free Survival(3years)
- Objective Response Rate(up to 24 weeks)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](through study completion, an average of 1 year)
研究者
研究点 (1)
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