250
Participants
Start Date
May 16, 2022
Primary Completion Date
June 30, 2029
Study Completion Date
June 30, 2032
Radiation therapy
"Participants will receive either 70 gray (Gy), 60 Gy, or 50 Gy of radiation based on the following criteria:~70 Gy: Pretreatment level of plasma circulating free HPV DNA (cfHPV DNA) ≤ 12 copies/mL~60 Gy: Tumor tissue positive for HPV subtype other than 16 OR Pretreatment level of cfHPV DNA 13-99 copies/mL OR Pretreatment level of cfHPV DNA ≥ 100 copies/mL AND \<95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy~50 Gy: Tumor tissue positive for HPV subtype 16, pretreatment level of cfHPV DNA ≥ 100 copies/mL, AND ≥ 95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy"
Cisplatin
"All participants will receive 40 mg/m2 of cisplatin intravenously over 60 minutes weekly during radiation therapy.~If cisplatin is not recommended by the treating medical oncologist or is not tolerated, it is permissible to switch to an alternative chemotherapy regimen per institutional practice, but chemotherapy should not be discontinued unless mandated by the patient's condition."
RECRUITING
Medical University of South Carolina, Charleston
RECRUITING
UF Health Proton Therapy Institute, Jacksonville
RECRUITING
University of Florida, Gainesville
Collaborators (1)
Naveris, Inc.
INDUSTRY
University of Florida
OTHER