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Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT05387915

Biomarker-Driven Radiation Therapy Dose Reduction After Transoral Robotic Surgery for the Treatment of HPV-Positive Oropharyngeal Cancer

A Phase 2 study testing Radiation Therapy in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Oropharyngeal HPV-Positive Squamous Cell Carcinoma, run by Emory University at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. Read more about this study

Who is it for?
Ages 18 years and older
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
33 participants
Where
3 sitesUnited States
Study dates
6 Jun 2022to 5 Jan 2028
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

  • Age >= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%).
  • Life expectancy > 12 weeks as determined by the Investigator.
  • Has diagnosis of HPV-associated squamous cell carcinoma of the oropharynx
  • HPV positive either via p16 status or via in situ hybridization
  • This includes patients with HPV positive squamous cell carcinoma of an unknown primary of the head and neck presumed to be of oropharyngeal origin who have undergone ipsilateral palatine and lingual tonsillectomies.
Show all 21Show fewer
  • pT1-2, pN0-1, cM0 disease.
  • Positive ctHPVDNA titer prior to surgery.
  • =< 10 pack-year smoking history.
  • Completed transoral robotic surgery (TORS) oropharyngectomy and at least ipsilateral neck dissection by an Emory otolaryngologist.
  • Pathology must demonstrate at least one of the follow intermediate risk factors:
  • Close margin (1 - 4 mm)
  • Perineural invasion
  • Lymphovascular space invasion
  • 2 - 4 positive lymph nodes without extranodal extension (ENE)
  • A single positive lymph node > 3 cm in size, without ENE
  • Pathology cannot demonstrate > 4 positive lymph nodes, ENE, or a positive final margin (defined as < 1 mm). Margins that have been subsequently cleared are allowed.
  • Radiation increases the risk of birth defects. For this reason, females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy.
  • FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of radiation. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months.
  • Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
  • Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.

Who cannot join

  • Patients with a prior history of malignancy in the last two years (excluding non- melanomatous skin cancer).
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1).
  • Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade >= 3 hypertension (diastolic blood pressure >= 100 mmHg or systolic blood pressure >= 160 mmHg) despite antihypertensive therapy.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Emory University Midtown Hospital

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Biomarker-Driven Radiation Dose Reduction After TORS in Patients With HPV-Positive Oropharyngeal Cancer

This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. A standard of care treatment for HPV positive oropharyngeal cancer is transoral robotic surgery followed by radiation therapy. However, this treatment is associated with many long-term side effects including difficulty swallowing. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving reduced dose radiation therapy after transoral robotic surgery may improve swallowing outcomes and quality of life compared to standard of care dose radiation therapy after transoral robotic surgery.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate swallow function among post-operative circulating tumor HPV deoxyribonucleic acid (ctHPVDNA)-negative patients treated with reduced intensity adjuvant radiation therapy (RT) doses as compared to historical controls from ECOG 3311.

SECONDARY OBJECTIVES:

  1. Evaluate progression free survival (PFS), overall survival (OS), and locoreginal control (LRC) among post-operative ctHPVDNA-negative patients treated with reduced adjuvant RT doses.

II. Evaluate PFS among post-operative ctHPVDNA-positive patients treated with standard of care adjuvant therapy.

OUTLINE:

Patients who are ctHPVDNA negative after surgery undergo reduced dose radiation therapy for 3 weeks (15 treatments). Patients who are ctHPVDNA positive after surgery undergo standard of care radiation therapy.

After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months.

Being tested
Radiation Therapy
Medical subject headings
Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated

    Undergo reduced dose radiation therapy

Study groups in NCT05387915
Study groupRoleWhat they receive
Treatment (reduced dose radiation therapy)ExperimentalPatients who are ctHPVDNA negative after surgery undergo reduced dose radiation therapy for 3 weeks (15 treatments). Patients who are ctHPVDNA positive after surgery undergo standard of care radiation therapy.
Receives: Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Swallowing Function Mean

    Will be assessed by the MD Anderson Dysphagia Index (MDADI) composite score (range 20 - 100, higher is better). Mean MDADI composite score will be reported at one year, along with a 95% confidence interval for the mean.

    Measured: At 1 year post surgery

  2. Swallowing Function T-Test

    A one-sample t-test will be conducted to compare the 1-year MDADI composite score with the null value of 79.1.

    Measured: At 1 year post surgery

Secondary outcomes (7)

  1. Progression-Free Survival (PFS)

    Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. A two-year PFS is of particular interest to compare to historical data (ECOG 3311), this specific estimate and its 95% confidence interval will be estimated from the Kaplan-Meier curve and compared descriptively to the same estimate from ECOG 3311 Arm B.

    Measured: From study entry to the earliest disease progression or death from any cause, assessed up to 24 months

  2. Overall Survival (OS)

    A two-year OS is of particular interest to compare to aforementioned historical controls; this specific estimate and its 95% confidence interval will be obtained from the Kaplan-Meier curve and compared descriptively to the same estimate from ECOG 3311 Arm B.

    Measured: From study entry to death due to any cause, assessed up to 24 months

  3. Locoregional Control (LRC)- Six Month

    LRC will be defined as the percentage of patients at a given timepoint that have not experienced recurrence of their disease at the primary site of their tumor in the oropharynx or in their neck. This will be analyzed in a similar manner to OS and PFS and compared to historical controls from ECOG 3311 Arm B.

    Measured: At 6 months

  4. Locoregional Control (LRC)- Two Year

    LRC will be defined as the percentage of patients at a given timepoint that have not experienced recurrence of their disease at the primary site of their tumor in the oropharynx or in their neck. This will be analyzed in a similar manner to OS and PFS and compared to historical controls from ECOG 3311 Arm B.

    Measured: At 2 years

  5. Quality of Life (QoL) - MD Anderson Symptom Inventory

    Quality of Life endpoints that are routinely collected and will continue to be collected on participants on this trial - MD Anderson Symptom Inventory - Head and Neck (MDASI-HN), Michigan Xerostomia, European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

    Measured: At 2 years

  6. Quality of Life (QoL) - Michigan Xerostomia

    Quality of Life endpoints that are routinely collected and will continue to be collected on participants on this trial - Michigan Xerostomia

    Measured: At 2 years

  7. Quality of Life (QoL) - European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L)

    Quality of Life endpoints that are routinely collected and will continue to be collected on participants on this trial - European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L)

    Measured: At 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start6 Jun 2022
  3. Primary completion5 Jan 2026
  4. Study completion5 Jan 2028 (estimated)

Resources

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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387915
Sponsor's protocol ID
STUDY00004187
Other IDs
NCI-2022-02855, WINSHIP5566-22, P30CA138292
Status last verified
Mar 2026
First submitted
17 May 2022
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Oropharyngeal HPV-Positive Squamous Cell Carcinoma, run by Emory University 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 21 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 1 Apr 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?

Swallowing Function Mean (time frame: At 1 year post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05387915.

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 1 Apr 2026.

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