HPV-Associated Oropharyngeal Squamous Cell CarcinomaPhase 2NCT05714657
Shortened Course Adjuvant Radiotherapy Following TORS
A Phase 2 study testing Shortened Course Adjuvant Radiotherapy Following TORS in people with HPV-Associated Oropharyngeal Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.
Trial summary
This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected HPV-Associated OPSCC patients receiving adjuvant radiation after TORS and neck dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV-Associated Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Shortened Course Adjuvant Radiotherapy Following TORS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jan 2023to 30 Dec 2027
- 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
- Patients ≥ 18 years old
- Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization
- Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed)
- Pathologic N0-N1 disease (per AJCC 8th Ed)
- Preoperative plasma ctHPVDNA of ≥ 50 copies/mL
- Undetectable postoperative plasma ctHPVDNA
- ECOG Performance Status 0-1
Who cannot join
- Prior external beam radiation therapy to the head and neck
- Presence of T4 disease
- ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition)
- Presence of distant metastatic disease
- Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected HPV-Associated OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.
Read the detailed description
This is a single-arm Phase II non-inferiority study of adjuvant radiation for locally-advanced HPV-Associated oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N1, M0 disease (per AJCC 8th Edition), detectable pre-operative and undetectable postoperative ctHPVDNA will be eligible. Patients will have undergone TORS primary site resection and neck dissection. Patients will undergo adjuvant RT +/- guideline-indicated chemotherapy. The neck and the primary site will be considered separately.
The primary objective of the study will be to determine the 2-year locoregional control (LRC) rate. Secondary objectives include measures of toxicity (as measured by CTCAE, version 5.0), patient-reported QOL (as measured by the MDASI and MDADI questionnaire), progression-free survival, metastasis-free survival, and overall survival. Differences between patients treated with IMRT and proton therapy in terms of toxicity and QOL will serve as another secondary objective.
- Being tested
- Shortened Course Adjuvant Radiotherapy Following TORS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortened Course Adjuvant Radiotherapy Following TORSRadiation
Shortened Course Adjuvant Radiotherapy Following TORS
| Study group | Role | What they receive |
|---|---|---|
| Shortened Course Adjuvant Radiotherapy | Experimental | The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week).
Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered. Receives: Radiation: Shortened Course Adjuvant Radiotherapy Following TORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control
To determine whether disease recurs locally (at primary site) or in regionally in the nodes of the neck
Measured: 2 years
Secondary outcomes (6)
Progression-free survival
To determine progression-free survival (any progression)
Measured: 2 Years
Metastasis-free survival
To determine metastasis-free survival (any distant metastasis)
Measured: 2 years
Overall survival
To determine overall survival (alive or not)
Measured: 2 years
Differences in toxicity between patients receiving IMRT and patients receiving PBT
To assess toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: 2 years
Patient-Reported Quality of Life using MDASI-HN
The MD Anderson Symptom Inventory - Head \& Neck (MDASI-HN)
- Minimum Value: 0
- Maximum Value: 280
- Higher scores mean worse outcome
Measured: 2 years
Patient-Reported Quality of Life using MDADI
The MD Anderson Dysphagia Inventory (MDADI)
- Minimum Value: 20
- Maximum Value: 100
- Higher scores mean better outcome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start30 Jan 2023
- Primary completion10 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Associated Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Lin, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714657
- Sponsor's protocol ID
- UPCC 06322
- Other IDs
- 852738
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05714657
- Acronym / sponsor ID
- UPCC 06322
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Feb 2023 (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.
This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected HPV-Associated OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.
Detailed description
This is a single-arm Phase II non-inferiority study of adjuvant radiation for locally-advanced HPV-Associated oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N1, M0 disease (per AJCC 8th Edition), detectable pre-operative and undetectable postoperative ctHPVDNA will be eligible. Patients will have undergone TORS primary site resection and neck dissection. Patients will undergo adjuvant RT +/- guideline-indicated chemotherapy. The neck and the primary site will be considered separately.
The primary objective of the study will be to determine the 2-year locoregional control (LRC) rate. Secondary objectives include measures of toxicity (as measured by CTCAE, version 5.0), patient-reported QOL (as measured by the MDASI and MDADI questionnaire), progression-free survival, metastasis-free survival, and overall survival. Differences between patients treated with IMRT and proton therapy in terms of toxicity and QOL will serve as another secondary objective.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shortened Course Adjuvant Radiotherapy | Experimental | Radiation: Shortened Course Adjuvant Radiotherapy Following TORSThe volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week). Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 18 years old
- Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization
- Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed)
- Pathologic N0-N1 disease (per AJCC 8th Ed)
- Preoperative plasma ctHPVDNA of ≥ 50 copies/mL
Key exclusion criteria (5 listed)
- Prior external beam radiation therapy to the head and neck
- Presence of T4 disease
- ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition)
- Presence of distant metastatic disease
- Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Shortened Course Adjuvant Radiotherapy Following TORSShortened Course Adjuvant Radiotherapy Following TORS | Radiation | Shortened Course Adjuvant Radiotherapy |
Primary outcome
Locoregional control
Time frame: 2 years
To determine whether disease recurs locally (at primary site) or in regionally in the nodes of the neck
6 secondary outcomes
Progression-free survival
Time frame: 2 Years
Metastasis-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Differences in toxicity between patients receiving IMRT and patients receiving PBT
Time frame: 2 years
Patient-Reported Quality of Life using MDASI-HN
Time frame: 2 years
Patient-Reported Quality of Life using MDADI
Time frame: 2 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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alexander Lin, MD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shortened Course Adjuvant Radiotherapy Following TORS in people with HPV-Associated Oropharyngeal Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine at 3 sites 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 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 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control (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 27 Oct 2026.