Phase II study of definitive chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal squamous cell carcinoma. (SP-RT)

Phase 2

• Conditions: Esophageal cancer

• Registration Number: JPRN-jRCTs051180078
• Lead Sponsor: Yamamoto Sachiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified