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 sites76 target enrollmentFebruary 27, 2019

Overview

No summary available.

Registry

who.int

Start Date

February 27, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yamamoto Sachiko

•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

•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