Shortened Radiation Therapy for HPV-Mediated Oropharyngeal Cancer
This study is looking at whether a shorter course of radiation therapy, called Reduced dose and Hypofractionated radiation therapy, can improve the quality of life for people who have had trans-oral robotic surgery for HPV-mediated oropharyngeal squamous cell carcinoma (a type of throat cancer linked to human papillomavirus). You might be able to join if you are 18 or older, have this type of cancer, and are eligible for trans-oral robotic surgery. The study will look at whether your quality of life, measured by FACT-HN (a questionnaire about head and neck cancer), stays the same or gets better six months after treatment compared to before. The study is currently accepting participants and plans to enroll 42 people.
- Study design
- This is an interventional study planning to enroll 42 participants. It is evaluating a specific radiation therapy approach.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life will be measured at 6 months post-treatment, with results evaluated at 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07044635
Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of UtahInvestigator-initiated
~42 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Radiation Therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stable or improved FACT-HN at 6 months post-treatment compared to baseline.
Measured over 2 years
Conditions
Where it's being run
1 sites across 1 statesUtah1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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
≥ 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.
Completion of trans-oral robotic surgery.
Pre- and post-operative TTMV-HPV DNA test results obtained.
Meets ANY of the following criteria:
Post-operative TTMV-HPV DNA positive or indeterminate
Surgical margin positive
\>1 mm extranodal extension
≥5 lymph nodes
Pre-operative TTMV-HPV DNA score of ≤ 50
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
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.
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.)
Pre-operative TTMV-HPV DNA score of \> 50.
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.).
What this trial measures
- Stable or improved FACT-HN at 6 months post-treatment compared to baseline.2 years
To evaluate if a shorter course of therapy can improve quality of life in patients receiving adjuvant radiation therapy after TORS.