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Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer

NCT06323460 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-24

No results posted yet for this study

Summary

This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood.

Conditions

  • Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Oropharyngeal Squamous Cell Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo PET/CT

RADIATION

External Beam Radiation Therapy

Undergo external beam radiotherapy

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Sujith Baliga · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06323460 on ClinicalTrials.gov