A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (NPC) (JCOG1015, IMRT for NPC)
Phase 3
- Conditions
- asopharyngeal cancer
- Registration Number
- JPRN-UMIN000005448
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Not provided
Exclusion Criteria
i) Simultaneous or metachronous (within 5 years) double cancers; ii) Systemic infections disease; iii) Body temperature of 38C or higher; iv) Women during pregnancy or breast-feeding; v) Psychiatric disease and/or depression; vi) Continuous systemic steroids medication; vii) Histoty of collagen diseases including rheumatism; viii) Uncontrollable diabetes mellitus or continuous administration of insulin; ix) treated with hemodialysis; x) Serious complications (COPD, pulmonary fibrosis, heart failure, etc.); xi) Myocardial infarction within 6 months or unstable angina pectoris.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (%3-year overall survival for clinical stage II-IVB)
- Secondary Outcome Measures
Name Time Method Progression-free survival (%3-year progression-free survival), locoregional progression-free surival (%3-year locoregional progression-free survival), location of first progression, %completion of protocol treatment, %grade 2 or more dry mouth (evaluated at the 1st, 2nd , 3rd year from IMRT start, CTCAE ver4.0), adverse events