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

NCT07044635 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: HCI191152
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oropharyngeal Squamous Cell Carcinoma; HPV-mediated Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Stable or improved FACT-HN at 6 months post-treatment compared to baseline.

  To evaluate if a shorter course of therapy can improve quality of life in patients receiving adjuvant radiation therapy after TORS.

  2 years

Secondary Outcomes (13)

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.

  2 years

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).

  2 years

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.

  2 years

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.

  2 years

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study drug.

  2 years

Study Arms (2)

10 fractions of radiation therapy

EXPERIMENTAL

Radiation: Radiation Therapy

Radiation therapy with chemotherapy, if applicable, per standard of care

ACTIVE COMPARATOR

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Reduced dose and Hypofractionated radiation therapy

10 fractions of radiation therapy; Radiation therapy with chemotherapy, if applicable, per standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant aged ≥ 18 years.
• Diagnosis of oropharyngeal squamous cell carcinoma.
• Eligible to receive transoral robotic surgery.
• If status is known, p16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor. If status not known at the time of step-1 registration, otherwise eligible participants may be enrolled and HPV/p16 status must be determined prior to step-2 registration.
• Pre-operative TTMV-HPV DNA test collected or is planned to be collected. Pre-operative TTMV-HPV DNA may be collected anytime up until the day of surgery as long as it is prior to surgery.
• 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.

You may not qualify if:

• 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.
• Step 2 Registration - Experimental Arm
• Completion of trans-oral robotic surgery.
• Pre- and post-operative TTMV-HPV DNA test results obtained.
• P16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor
• For participants of childbearing potential: Negative pregnancy test or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
• \< 50 years of age:
• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
• Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Rachel Kingford

CONTACT

8015850115; rachel.kingsford@hci.utah.edu

Shane Lloyd

CONTACT

801-585-0255; shane.lloyd@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)