NIPH Clinical Trials Search

UMIN ID: UMIN000001272

Registered date:28/07/2008

Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedunresectable locally advanced squamous cell carcinoma of the head and neck
Date of first enrollment2008/07/01
Target sample size45
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Concurrent chemoradiotherapy with S-1 and cisplatin


Primary Outcomecomplete clinical remission rate
Secondary Outcomelocal progression-free survival, progression-free survival, time to treatment failure, overall survival, proportion of nutritional support-free survival, adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) Active bacterial or fungous infection 2) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor. 3) Pregnant or lactating women or women of childbearing potential 4) Active gastrointestinal bleeding 5) Pleural effusion, pericardial effusion, or severe ascites 6) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months. 7) Cerebrovascular disease within 6 months 8) Uncontrollable diabetes mellitus or requiring administration of insulin 9) Uncontrollable hypertension 10) Chronic pancreatitis 11) Positive HBs antigen 12) Impossible to refrain from smoking and drinking during treatment 13) Requiring systemic steroids medication

Related Information


public contact
Name Makoto Tahara
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN Japan
Telephone 04-7133-1111
Affiliation JCOG0706 Coordinating Office Department of gastrointestinal onclolgy, National Cancer Center Hospital East
scientific contact
Name Masato Fujii
Address 2-5-1, Higashigaoka, Meguro-ku, Tokyo 152-8902, JAPAN Japan
Telephone 03-3411-0111
Affiliation National Hospital Organization Tokyo National Medical Center Department of otolaryngology