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)

UMIN ID: UMIN000001272

Registered date:28/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: unresectable locally advanced squamous cell carcinoma of the head and neck
• Date of first enrollment: 2008/07/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Concurrent chemoradiotherapy with S-1 and cisplatin

Outcome(s)

• Primary Outcome: complete clinical remission rate
• Secondary Outcome: local 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 minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: Japan Clinical Oncology Group (JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare