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

NCT06234748 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-05-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Michelle Mierzwa · University of Michigan Rogel Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06234748 on ClinicalTrials.gov