JPRN-jRCTs031200094进行中（未招募）2 期
Multicenter phase II trial to evaluate the safety and efficacy of FLOT therapy for resectable esophageal squamous cell carcinoma - Preoperative FLOT PII
Kawakubo Hirofumi0 个研究点目标入组 60 人开始时间: 2020年8月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid)
- •2. Primary tumor is located mainly in the thoracic esophagus
- •3. cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1)
- •4. Twenty years old or older as of registration
- •5. Performance status (PS) 0 or 1
- •6. Patients have target lesions
- •7. No previous history of esophageal cancer except for the followings
- •1) pT1a-LPM (M2) or deeper following EMR/ESD
- •2) pT1a-MM (M3) with vascular invasion following EMR/ ESD
- •8. No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval
- •9. Patients who meet the following criteria
- •1) Neutrophil>1,500 /mm3
- •2) Platelet>10.0x10^4 /mm3
- •3) Hb>=9.0 g/dL
- •4) Total bilirubin<=1.5 mg/dL
- •5) AST<=100 IU/L
- •6) ALT<=100 IU/L
- •7) SpO2>=95 %
- •8) Creatinine clearance<=50 mL/min
- •10. Patients who can undergo esophagectomy
- •11. Agree with the participation to the current study
排除标准
- •1. Patients who received any treatment for cancer within 3 years
- •2. Patients who have active infectious diseases
- •3. HBs Ag positive or HIV Ab positive
- •4. Pregnant or breast feeding
- •5. Patients with psychological disorder
- •6. On systemic steroid therapy
- •7. Require flucytocine, phenytoin, warfarin
- •8. Allergic to iodine
- •9. Allergic to DTX, LOHP, polisorbate 80
- •10. Uncontrollable diabetes
- •11. Severe COPD or lung fibrosis
- •12. Severe hypertension
- •13. Unstable angina
- •14. Patients whom investigators evaluate as ineligible
研究者
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