NCT04699994招募中2 期
Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)
研究概览
简要总结
The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid)
- •Primary tumor is located mainly in the thoracic esophagus
- •cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1)
- •Twenty years old or older as of registration
- •Performance status (PS) 0 or 1
- •Patients have target lesions
- •No previous history of esophageal cancer except for the followings
- •pT1a-LPM (M2) or deeper following EMR/ESD 2) pT1a-MM (M3) with vascular invasion following EMR/ ESD
- •No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval
- •Patients who meet the following criteria
- •Neutrophil > 1,500 /mm3
- •Platelet > 10.0x10^4 /mm3
- •Hb ≧9.0 g/dL
- •Total bilirubin ≦ 1.5 mg/dL
- •AST ≦ 100 IU/L
- •ALT ≦ 100 IU/L
- •SpO2 ≧ 95 %
- •Creatinine clearance ≧ 50 mL/min
- •Patients who can undergo esophagectomy
- •Agree with the participation to the current study
排除标准
- •Patients who received any treatment for cancer within 3 years
- •Patients who have active infectious diseases
- •HBs Ag positive or HIV Ab positive
- •Pregnant or breast feeding
- •Patients with psychological disorder
- •On systemic steroid therapy
- •Require flucytocine, phenytoin, warfarin
- •Allergic to iodine
- •Allergic to DTX, LOHP, polisorbate 80
- •Uncontrollable diabetes
- •Severe COPD or lung fibrosis
- •Severe hypertension
- •Unstable angina
- •Patients whom investigators evaluate as ineligible
研究组 & 干预措施
FLOT therapy
Experimental
干预措施: FLOT therapy (Drug)
结局指标
主要结局
Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)
时间窗: 2.5 years
次要结局
- Late phase complication rate(4.5 years)
- Incidence rate of all adverse event(4.5 years)
- Incidence rate of adverse event during FLOT(2.5 years)
- Incidence rate of severe adverse event(2.5 years)
- Response rate(2.5 years)
- Treatment completion rate(2.5 years)
- Perioperative complication rate(2.5 years)
- Histological complete response rate(2.5 years)
- Curative resection rate(2.5 years)
- Recurrence free survival(4.5 years)
- Overall survival(4.5 years)
研究者
Hirofumi Kawakubo
Associate Professor
Keio University
研究点 (1)
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