Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck (JCOG1008, HNC-Adjuvant CDDP+RT-P3)
Phase 2
- Conditions
- locally advanced squamous cell carcinoma of the head and neck
- Registration Number
- JPRN-UMIN000009125
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
Not provided
Exclusion Criteria
1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor. 2) Active systemic infections to be treated. 3) Body temperature of 38 or more degrees Celsius 4) Women during pregnancy, possible pregnancy, or breast-feeding 5) Psychiatric disease 6) Continuous systemic steroid treatment 7) Uncontrolled diabetes mellitus 8) History of unstable angina pectoris or myocardial infarction within 6 months 9) Uncontrolled hypertension 10) Pleural effusion, pericardiac effusion, or ascites to be drained 11) Positive HBs antigen 12) Impossiblility to refrain from smoking or drinking during protocol treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival (phase III), proportion of treatment completion (phase II)
- Secondary Outcome Measures
Name Time Method relapse-free survival, local relapse-free survival, nutrition support free survival, adverse events, non-hospitalized treatment period during permissible treatment period, non-hospitalized treatment period during 90 days after the start of protocol treatment