HPV-associated oropharyngeal squamous cell carcinoma HPV-associated oropharyngeal squamous cell carcinoma
Conditions
Interventions
Radiation therapy, chemotherapy
Sponsors
Inohara Hidenori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, histologically diagnosed squamous cell carcinoma of the oropharynx, p16 positive on immunostaining and HPV16 DNA positive by PCR 2, cT1-2 N1-2b M0 or cT3 N0-2b M0 3, detectable ctHPVDNA within 30 days prior to enrollment 4, performance status 0 or 1 5, measurable disease 6, no previous treatment for the current disease 7, no prior chemotherapy with platinum and no prior radiotherapy in the neck 8, no dysfunctional vital organs blood test within 30 days prior to enrollment should be a, neutrophil count of 1,500/mm3 or more b, Hb of 10.0 g/dL or more c, platelet count of 100 x 103/mm3 or more d, total bilirubin of 1.5 mg/dL or less e, AST of 100 U/L or less f, ALT of 100 U/L or less g, creatine clearance of 60 mL/min or more 9, age at consent to participate in this study should be 18 to 85 years old 10, life expectancy of more than 6 months at consent 11, consent can be obtained from the subject him or herself
Exclusion criteria
Exclusion criteria: 1, active second primary malignancies 2, infectious disease requiring systemic therapy 3, body temperature of 38 Celsius degree or above at the time of enrollment 4, females with pregnant, possible pregnant, within 28 days after delivery, or under breast-feeding. males who want to have a child with his partner 5, mental disorders which may cause difficulties to participate in this trial 6, under treatment with corticosteroid or other immunosuppressive agents 7, serum HBs antigen positive 8, serum HIV antibody positive 9, current smoker 10, ctHPVDNA<10 copy/mL within 30 days prior to enrollment 11, ctHPVDNAof 5,000 copy/mL or more within 30 days prior to enrollment 12, intratumoral HPV DNA <2 copy/cell 13, anatomically unresectable disease 14, subjects whom doctors in charge considered ineligible for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete molecular response rate the proportion of patients who have negative results for ctHPVDNA at the time of 12 week post-radiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete metabolic response rate (the proportion of patients with no FDG at the time of 12 week post-radiation intake at the tumor sites) Progression free survival Overall survival Recurrence-free survival Adverse events QOL | — |
Contacts
Public ContactTadashi Yoshii
The University of Osaka Hospital
Outcome results
None listed