Trials / Recruiting

RecruitingNCT06323460

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

A Pilot Study of Adaptive De-Intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 45 (estimated)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the 3-month post-treatment positron emission tomography (PET) response rate in patients who have a favorable tumor tissue modified viral (TTMV) tumor profile (defined as \>= 200 copies/mL and reduced to \> 95% of this value by week 4). SECONDARY OBJECTIVES: I. To assess 2-year progression free survival and toxicity in the reduced dose chemo-radiation arm. II. To determine acute and late toxicity as measured by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0). III. To compare changes in the MD Anderson Dysphagia Inventory (MDADI) of reduced dose radiation to the current standard of care (69.96 Gy). IV. To determine whether integration of HPV into the host genome is associated with circulating TTMV clearance profiles during chemoradiation (CRT). OUTLINE: Patients undergo external beam radiotherapy daily for 5 days a week for 4 weeks. Patients also receive cisplatin intravenously (IV) weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 4 weeks. Patients undergo blood sample collection for circulating tumor DNA testing at week 4, and then are assigned to 1 of 2 arms based on the results. ARM I: Patients with reduced \> 95% of TTMV undergo external beam radiotherapy once daily (QD)5 days a week for 5 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 5 weeks. Patients undergo PET/computed tomography (CT) scan throughout the trial. Patients also undergo blood sample collection during screening and throughout the trial. ARM II: Patients without reduced \> 95% of TTMV undergo external beam radiotherapy daily for 5 days a week for 7 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 7 weeks. Patients undergo PET/CT scan throughout the trial. Patients also undergo blood sample collection during screening and throughout the trial. After completion of study treatment, patients are followed every 3 months for up to 24 months.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2024-03-21
Primary completion: 2026-12-31
Completion: 2026-12-31
First posted: 2024-03-21
Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06323460. Inclusion in this directory is not an endorsement.