NCT05268614

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

Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma Based on HPV Subtype and Plasma Circulating Free HPV DNA Level and Clearance Rate

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Conditions

• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
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) ≤ 3 copies/mL 60 Gy: Tumor tissue positive for HPV subtype other than 16 OR Pretreatment level of cfHPV DNA 4-99 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.

Timeline

• Start date: 2022-05-16
• Primary completion: 2029-06-01
• Completion: 2032-06-01
• First posted: 2022-03-07
• Last updated: 2026-02-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study