RECRUITING

Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.

Conditions

Oropharyngeal Squamous Cell Carcinoma HPV-mediated Oropharyngeal Squamous Cell Carcinoma

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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

The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after trans-oral robotic surgery.

Official Title

Radiation Therapy in Reduced Dose and Hypofractionated Schedule After Trans-Oral Robotic Surgery in Intermediate Risk HPV-Mediated Oropharyngeal Squamous Cell Carcinoma

Quick Facts

Study Start:2025-07-23

Study Completion:2030-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07044635

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 Criteria	Exclusion Criteria
* Participant aged ≥ 18 years. * Diagnosis of oropharyngeal squamous cell carcinoma. * Eligible to receive transoral robotic surgery. * P16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor. * Pre-operative TTMV-HPV DNA test collected. * Standard of care tests completed within 60 days of registration may be used for screening. * Tests results are not required to confirm eligibility for step 1 registration. * ECOG Performance Status ≤ 2 * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.	* History of prior mucosal head and neck cancer treated with radiation therapy * Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study * Participant has smoked cigarettes within 1 month of registration * Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter. * Known distant metastatic disease. * Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[participants may not receive the drug through a feeding tube\], social/ psychological issues, etc.) * Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.

Inclusion Criteria

Exclusion Criteria

* Participant aged ≥ 18 years.
* Diagnosis of oropharyngeal squamous cell carcinoma.
* Eligible to receive transoral robotic surgery.
* P16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor.
* Pre-operative TTMV-HPV DNA test collected.
* Standard of care tests completed within 60 days of registration may be used for screening.
* Tests results are not required to confirm eligibility for step 1 registration.
* ECOG Performance Status ≤ 2
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

* History of prior mucosal head and neck cancer treated with radiation therapy
* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study
* Participant has smoked cigarettes within 1 month of registration
* Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
* Known distant metastatic disease.
* Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[participants may not receive the drug through a feeding tube\], social/ psychological issues, etc.)
* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.

Contacts and Locations

Study Contact

Rachel Kingford

CONTACT

8015850115

rachel.kingsford@hci.utah.edu

Shane Lloyd

CONTACT

801-585-0255

shane.lloyd@hci.utah.edu

Study Locations (Sites)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

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 Date2025-07-23

Study Completion Date2030-08

Study Record Updates

Study Start Date2025-07-23

Study Completion Date2030-08

Terms related to this study

Additional Relevant MeSH Terms

Oropharyngeal Squamous Cell Carcinoma
HPV-mediated Oropharyngeal Squamous Cell Carcinoma