Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU for clinical stage IA-IIIC esophageal cancer.(PCF-RT) - Phase I study of PCF-RT

Yamamoto Sachiko0 个研究点目标入组 24 人开始时间: 2019年2月28日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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 75 years old
•4) ECOG PS of 0 or 1
•5) Clinical stage IA - IIIC
•6) No need for measurable lesion
•7) No previous treatment of esophageal cancer except endoscopic surgery
•8) No palsy of recurrent nerve
•9) No adaptation of surgery or refused esophagectomy
•10) Adequate organ functions
•11) Written informed consent

•1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer or expected cure in surgery
•2) history of radiotherapy for mediastinum
•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 platinum, polyoxy-ethilen oil, hydrogenated castor oil or polysorbate 80
•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

发起方

Yamamoto Sachiko