Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

May 16, 2022

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2032

Conditions
Oropharyngeal Squamous Cell Carcinoma
Interventions
RADIATION

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"

DRUG

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."

Trial Locations (3)

29425

RECRUITING

Medical University of South Carolina, Charleston

32206

RECRUITING

UF Health Proton Therapy Institute, Jacksonville

32610

RECRUITING

University of Florida, Gainesville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Naveris, Inc.

INDUSTRY

lead

University of Florida

OTHER

NCT05268614 - Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter