RECRUITING

Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.

Official Title

A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

Quick Facts

Study Start:2024-03-07
Study Completion:2027-10-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06088381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jason K Molitoris, MD, PhD
CONTACT
410-328-6080
jmolitoris@umm.edu
Kelly Kitzmiller, MPH
CONTACT
410-369-5264
kelly.kitzmiller@umm.edu

Principal Investigator

Jason K Molitoris, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Maryland/Maryland Proton Treatment Center

Study Locations (Sites)

Maryland Proton Treatment Center
Baltimore, Maryland, 21201
United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
Upper Chesapeake Health
Bel Air, Maryland, 21014
United States
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
United States
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Jason K Molitoris, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Maryland/Maryland Proton Treatment Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-07
Study Completion Date2027-10-18

Study Record Updates

Study Start Date2024-03-07
Study Completion Date2027-10-18

Terms related to this study

Keywords Provided by Researchers

  • Transoral Robotic Surgery (TORS)
  • Head and Neck Cancer
  • Oropharynx Cancer
  • HPV p16 Oropharynx Cancer
  • Proton Therapy
  • Photon Therapy

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Oropharynx Cancer
  • Oropharynx Squamous Cell Carcinoma
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma