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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)

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 Sachiko

Osaka International Cancer Institute

3-1-69 Otemae, Chuo-ku, Osaka-shi, Osaka, 541-8567 Japan

yamamoto-sa@mc.pref.osaka.jp

Yamamoto Sachiko

Osaka International Cancer Institute

3-1-69 Otemae, Chuo-ku, Osaka-shi, Osaka, 541-8567 Japan

+81-6-6945-1181

yamamoto-sa@mc.pref.osaka.jp

Not Recruiting

June. 01, 2014

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Esophageal cancer

Concurrent chemoradiotherapy with S-1 and cisplatin

Esophageal cancer

1) without endoscopic surgery Complete response rate
2) with endoscopic surgery 3-year survival rate

Overall survival, Progression free survival, Adverse event

+81-6-6945-1181

Feb. 15, 2019

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