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

Launched by UNIVERSITY OF UTAH · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether giving a shorter course of radiation therapy after a type of surgery called trans-oral robotic surgery can help improve the quality of life for people with a throat cancer caused by HPV (human papillomavirus). This type of cancer affects the oropharynx, which is the middle part of the throat. Researchers want to see if reducing the length of radiation treatment can still be effective while making the experience easier and less tiring for patients.

People who may be eligible for this study are adults diagnosed with HPV-related oropharyngeal cancer who are able to have the robotic surgery. Participants need to have certain test results showing HPV involvement and be healthy enough to take part (able to perform daily activities without too much difficulty). After surgery, patients will have more tests to determine if they fit into the study’s treatment group. Those who join can expect to receive radiation therapy but over a shorter time than usual. The study is not yet recruiting, and people who have had recent smoking, previous head and neck radiation, or other serious health issues may not qualify. This trial aims to find a balance between effective cancer treatment and maintaining patients’ well-being during and after therapy.

Gender

ALL

Eligibility criteria

• • Step 1 Registration: Pre-Operative Eligibility
• 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.
• 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
• Inclusion Criteria:
• • 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:
• * 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.)