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ACTIVE NOT RECRUITING
NCT06234748
PHASE2

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

Sponsor: University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2023-12-20

Completion Date

2026-07

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

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

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States