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

NCT ID: NCT07044635

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-23
• Study Completion Date: 2030-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 fractions of radiation therapy

Group Type: EXPERIMENTAL

Radiation Therapy

Intervention Type: RADIATION

Reduced dose and Hypofractionated radiation therapy

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

Group Type: ACTIVE_COMPARATOR

Radiation Therapy

Intervention Type: RADIATION

Reduced dose and Hypofractionated radiation therapy

Interventions

Radiation Therapy

Reduced dose and Hypofractionated radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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.

• Completion of trans-oral robotic surgery.
• Pre- and post-operative TTMV-HPV DNA test results obtained.
• For participants of child bearing 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
• ≥ 50 years of age:

• Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
• Had radiation-induced menopause with last menses >1 year ago; or
• Had chemotherapy-induced menopause with last menses >1 year
• Participants of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.5.2.

Exclusion Criteria

• 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

• Meets ALL of the following criteria for low-risk disease (Note: participants may meet some without being excluded):

• Pre-operative TTMV-HPV DNA positive
• Post-operative TTMV-HPV DNA negative
• Disease: pT1 with ≤ 1 lymph nodes OR pT2N0
• <10 pack year smoking
• No extranodal extension
• Negative surgical margins
• No perineural invasion
• No lymphovascular invasion
• Meets ANY of the following criteria for high-risk:

• Post-operative TTMV-HPV DNA positive
• Surgical margin positive -->1 mm extranodal extension --≥ 5 lymph nodes
• 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Kingford

Role: CONTACT

rachel.kingsford@hci.utah.edu

8015850115

Shane Lloyd

Role: CONTACT

shane.lloyd@hci.utah.edu

801-585-0255

Facility Contacts

Rachel Kingsford

Role: primary

rachel.kingsford@hci.utah.edu

801-585-0115

Shane Lloyd

Role: backup

shane.lloyd@hci.utah.edu

801-585-0255

Other Identifiers

HCI191152

Identifier Type: -

Identifier Source: org_study_id