p16-positive oropharyngeal cancer
Conditions
Interventions
Reduce the dose to the prophylactic lymph node regions from the standard 46Gy/23fr to 30Gy/15fr in chemoradiotherapy for p16-positive oropharyngeal cancer.
Sponsors
Kita Nozomi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 20-75 years, inclusive 2) ECOG Performance Status (PS): 0-1 3) p16-positive oropharyngeal cancer, Stage I-III (excluding T1N0M0) 4) Judged as appropriate for chemoradiotherapy by a multidisciplinary tumor board 5) Judged eligible for at least one cycle of concurrent cisplatin (CDDP) at 80-100 mg/m2 based on adequate organ function 6) Voluntary written informed consent obtained from the patient after sufficient understanding of the study
Exclusion criteria
Exclusion criteria: 1) Presence of active concomitant malignancy (synchronous, or metachronous with a disease-free interval of 3 years or less) 2) Prior radiation therapy to the head and neck region 3) Patients who are pregnant or potentially pregnant 4) Patients who are unable to provide informed consent 5) Patients deemed unsuitable for this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year locoregional control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) 2-year overall survival rate 2) Complete response rate 3) 2-year progression-free survival 4) 2-year locoregional progression-free survival 5) 2-year incidence of adverse events 6) QOL score | — |
Contacts
Public ContactNozomi Kita
Department of Radiology, Nagoya City University Graduate School of Medical Sciences
Outcome results
None listed