Oropharyngeal Squamous Cell CarcinomaPhase 2RAD RAPTORSNCT07044635
Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.
A Phase 2 study testing Radiation Therapy in people with Oropharyngeal Squamous Cell Carcinoma and HPV-mediated Oropharyngeal Squamous Cell Carcinoma, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma, HPV-mediated Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). 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.
Who cannot join
- 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.)
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- 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 (lymph node must be <3 cm) 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.)
- Step 2 Registration - Exploratory Arm Inclusion Criteria
- 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 or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). 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.
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, rachel.kingsford@hci.utah.edu
Shane Lloyd, 801-585-0255, shane.lloyd@hci.utah.edu
About this study
Official title: Radiation Therapy in Reduced Dose and Hypofractionated Schedule After Trans-Oral Robotic Surgery in Intermediate Risk HPV-Mediated Oropharyngeal Squamous Cell Carcinoma
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.
- Being tested
- Radiation Therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Reduced dose and Hypofractionated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 10 fractions of radiation therapy | Experimental | Not described Receives: Radiation: Radiation Therapy |
| Radiation therapy with chemotherapy, if applicable, per standard of care | Active comparator | Not described Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (13)
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
Measured: 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).
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
Measured: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
Measured: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
Measured: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study drug.
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
Measured: 2 years
Progression-free survival (PFS) as defined as the time from surgery to the time of recurrence or death from any cause.
To assess PFS at 1-year post-radiation.
Measured: 4 years
Overall survival (OS) as defined as the time from registration until death from any cause.
To assess overall survival in this study population.
Measured: 4 years
The proportion of participants who experience local-regional recurrence.
To assess the local-regional recurrence rate.
Measured: 4 years
The proportion of participants who experience distant recurrence.
To assess the distant recurrence rate.
Measured: 4 years
The proportion of participants who experience recurrence.
To assess the overall recurrence rate.
Measured: 4 years
Stable or improved MDADI defined by patient quality of life.
To assess patient-reported quality of life.
Measured: 4 years
Stable or improved FACT-HN at 12 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.
Measured: 4 years
This endpoint is restricted to participants who are able to work prior to treatment. Of those participants, the proportion who remain able to work 6 months after treatment as assessed by the FACT-HN.
To evaluate the ability for participants to return to work after a shorter course of adjuvant radiation therapy following TORS.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start23 Jul 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044635
- Sponsor's protocol ID
- HCI191152
- Acronym
- RAD RAPTORS
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy in Reduced Dose and Hypofractionated Schedule After Trans-Oral Robotic Surgery in Intermediate Risk HPV-Mediated Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07044635
- Acronym / sponsor ID
- RAD RAPTORS / HCI191152
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 fractions of radiation therapy | Experimental | Radiation: Radiation Therapy |
| Radiation therapy with chemotherapy, if applicable, per standard of care | Active comparator | Radiation: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (41 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyReduced dose and Hypofractionated radiation therapy | Radiation | 10 fractions of radiation therapy, Radiation therapy with chemotherapy, if applicable, per standard of care |
Primary outcome
Stable or improved FACT-HN at 6 months post-treatment compared to baseline.
Time frame: 2 years
To evaluate if a shorter course of therapy can improve quality of life in patients receiving adjuvant radiation therapy after TORS.
13 secondary outcomes
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
Time frame: 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).
Time frame: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Time frame: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
Time frame: 2 years
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study drug.
Time frame: 2 years
Progression-free survival (PFS) as defined as the time from surgery to the time of recurrence or death from any cause.
Time frame: 4 years
Overall survival (OS) as defined as the time from registration until death from any cause.
Time frame: 4 years
The proportion of participants who experience local-regional recurrence.
Time frame: 4 years
The proportion of participants who experience distant recurrence.
Time frame: 4 years
The proportion of participants who experience recurrence.
Time frame: 4 years
Stable or improved MDADI defined by patient quality of life.
Time frame: 4 years
Stable or improved FACT-HN at 12 months post-treatment compared to baseline.
Time frame: 4 years
This endpoint is restricted to participants who are able to work prior to treatment. Of those participants, the proportion who remain able to work 6 months after treatment as assessed by the FACT-HN.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Therapy in people with Oropharyngeal Squamous Cell Carcinoma and HPV-mediated Oropharyngeal Squamous Cell Carcinoma, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Kingford (8015850115, rachel.kingsford@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stable or improved FACT-HN at 6 months post-treatment compared to baseline. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.