NCT06234748

Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

Pilot Phase II Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to study the population of HPV-related oropharynx cancer patients that appear to be at highest risk for treatment failure with loco-regional failure and distant metastases including cT4 or cN3. The study team aims to determine if it is feasible to use multi-modality imaging (both DCE MRI and FDG-PET) to optimize the radiation boost in high risk p16+ OPSCC with similar or decreased toxicity compared to historic standard therapy.

Conditions

• Oropharynx Cancer
• HPV-Related Carcinoma

Interventions

Type	Name	Description
RADIATION	Radiation	Patients will undergo 2 phases of RT replanning: 1. Based on 2-week DCE-MRI low BV tumor subvolume, patients will have a PTVboost1 that will start to receive 2.5Gy/day with fraction 16. PTVboost1=(persistent lowBVsubvolume\_2 wks+ MTV3\_2 weeks)+ 3mm margin. 2. Based on 4-week FDG-PET MTV3, patients with have a PTVboost2 cone down that will receive 2.5Gy/day starting with fraction 23. PTVboost2=(LBV\_2 wks + MTV3\_4wks)+ 3mm margin 3. Thus, the tumor subvolumes that are included in the boost from fx16-35 will receive 86 Gy EQD2 (80Gy physical dose) and the FDG-avid subvolumes which start boost at 2 weeks but are not persistently avid at 4 wks will receive 76Gy EQD2 (74Gy physical dose).
DRUG	Platinum based chemotherapy	Standard of care therapy, weekly, with either Cisplatin or Carboplatin

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-01-31
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study