Nasopharyngeal cancer
Conditions
Interventions
Concurrent chemoradiotherapy with two-step IMRT (70 Gy/ 35 fr/ 47 days) and three cycles of cisplatin (80 mg/m2, day 1, q3w) follwed by three cycles of adjuvant chemotherapy with 5-FU (700 mg/m2, day
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Pathologically proven nasopharyngeal cancer based on the biopsy from the tumor or metastatic lymph nodes (either type I, II or III by WHO classification 1978 is eligible) ; ii) Clinical stage II-IVB (UICC 7th edition, 2009) ; iii) Aged 20 to 75 years old; iv) ECOG PS of 0 or 1; v) No prior chemotherapy against any malignancies, no prior radiation therapy for brain, head or neck resion, no prior surgery for head and neck cancer; vi) Sufficeient organ functions; vii) No ECG abnormalities; viii) Written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (%3-year overall survival for clinical stage II-IVB) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYasumasa Nishimura
JCOG1015 Coordinating Office Department of Radiation Oncology, Kinki University Faculty of Medicine
Outcome results
None listed