De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA

Summary

This phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving chemotherapy along with radiation may kill more tumor cells. However, the cancer can recur or can spread to other parts of the body and all treatments can be associated with side effects. The purpose of this study is to evaluate a blood-based biomarker, using the NavDx testing device, for head and neck cancers in order to see if it can help improve selection of the intensity of treatment in order to best balance the side effects of treatment with the goal of decreasing cancer recurrence. This test could aid in early detection of recurrence and salvage therapy.

Conditions

• Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma
• Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and saliva specimen collection for NavDx testing

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

RADIATION

Diffusing Alpha-emitter Radiation Therapy

Undergo DART

DRUG

Docetaxel

Given IV

PROCEDURE

Intensity-Modulated Proton Therapy

Undergo IMPT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Modified Barium Swallow Study

Undergo MBSS

OTHER

Observation Activity

Undergo observation

PROCEDURE

Positron Emission Tomography

Undergo PET scan

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire

Ancillary studies

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• David M, Routman, M.D. · Mayo Clinic in Rochester

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-21

Primary Completion

2028-08-01

Completion

2029-08-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations