Oropharyngeal cancer
Conditions
Interventions
Radiotherapy with two-step IMRT (70 Gy/ 35 fr/ 47 days).
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Clinically diagnosed of oropharyngeal cancer ii) Pathologically proven squamous cell carcinoma based on the biopsy from the tumor iii) Subsites including tonsil without invasion to the base of tongue, base of the tongue, or soft palate iv) cT1-2N0-1M0 (UICC 7th edition, 2009), no synchronous double/multiple cancer v) In case of cN0, not a candidate for transoral approach surgery vi) Planned treatment period within 52 days vii) Aged 20 to 80 years old viii) ECOG PS of 0 or 1 ix) No prior chemotherapy for any malignancies, no prior radiation therapy for brain, head or neck region, no prior surgery for head and neck cancer x) Sufficient organ functions xi) Written informed consent
Exclusion criteria
Exclusion criteria: i) Simultaneous or metachronous (within the past 5 years) malignancies ii) Infectious disease requiring systemic treatment iii) Body temperature of 38 degrees Celsius or higher iv) Pregnant or lactating women or women of childbearing potential v) Psychiatric disease vi) Continuous systemic steroids or immunosuppressive medication vii) History of collagen diseases including rheumatism viii) Diabetes mellitus treated with routine administration of insulin or poorly controlled ix) Treated with hemodialysis x) Serious complications (COPD, pulmonary fibrosis, heart failure, etc.) xi) Myocardial infarction within 6 months or unstable angina pectoris xii) Cardiac pacemaker or ICD recipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (%3-year overall survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (%3-year progression-free survival), loco-regional progression-free survival (%3-year loco-regional progression-free survival), loco-regional control (%3-year loco-regional control), site of first progression, proportion of protocol treatment completion within recommended treatment time, grade 2 or more xerostomia (evaluated at 3, 6, 12, 18, 24, 36 months from IMRT start, CTCAE ver4.0-JCOG), adverse events | — |
Countries
Japan
Contacts
Public ContactSatoaki Nakamura
JCOG1208 Coordinating Office Department of Radiation Oncology, Kansai Medical University Hospital
Outcome results
None listed