JPRN-jRCTs051180078进行中（未招募）2 期
Phase II study of definitive chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal squamous cell carcinoma. (SP-RT) - Phase II study of SP-RT
Yamamoto Sachiko0 个研究点目标入组 76 人开始时间: 2019年2月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
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 <= 80age old（—）
- 性别
- All
入选标准
- •1) Histologically proven squamous cell carcinoma, or adenosquamous cell carcinoma or basaloid of the esophagus
- •2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
- •3) Aged 20 to 80 years old
- •4) ECOG PS of 0, 1 or 2
- •5) Clinical stage IA (cT1a or cT1bN0M0) or pT1 which need therapy
- •6) No need for measurable lesion
- •7) No previous treatment of esophageal cancer (surgery, radiotherapy, chemotherapy),except for endoscopic surgery.
- •8) Adequate food intake
- •9) No palsy of recurrent nerve
- •10) Adequate organ functions
- •11) Refused esophagectomy
- •12) Written informed consent
排除标准
- •1) Simultaneous or metachronous double cancers, with the exception of patients curable with therapy before diagnosis of esophageal cancer and patients with superficial cancer that is curable even before local treatment
- •2) Patients requiring the administration of phenytoin or warfarin potassium
- •3) Uncontrollable diabetes mellitus
- •4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac function disorder
- •5) Uncontrollable arrhythmia
- •6) Patients requiring systemic steroids medication
- •7) Liver cirrhosis
- •8) Active bacterial or fungous infection
- •9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0
- •10) With a history of grade 2-4 nerve disturbance by CTCAE version 4.0
- •11) With blood transfusion within 2weeks and/or active bleeding
- •12) Interstitial pneumonia, fibroid lung or severe emphysema
- •13) With a history of allergic reaction to tegafur (FT), gimestat (CDHP), otastat potassium (Oxo) or platinum
- •14) Psychosis
- •15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future
- •16) Any patients judged by the investigator to be unfit to participate in the study
研究者
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