Could less radiation be just as good for HPV throat cancer?
NCT ID NCT05387915
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving a lower dose of radiation after robotic surgery can help people with HPV-positive throat cancer have fewer side effects, like trouble swallowing, while still controlling the cancer. About 33 adults with this type of cancer will receive the reduced radiation and be followed for one year to check their swallowing function and cancer outcomes. The goal is to improve quality of life without making the cancer more likely to return.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2022
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Clinical stage I HPV-mediated (P16-positive) oropharyngeal carcinoma ajcc V8 are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
-
Emory University Midtown Hospital
Atlanta, Georgia, 30308, United States
-
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- MRI scans may reveal which throat cancer patients need stronger treatment
- Can a DNA vaccine boost immunotherapy against HPV-Linked head and neck cancer?
- A gentler path after surgery for HPV throat cancer?
- Blood test may tailor throat cancer treatment, sparing patients from harsh side effects
- Robotic surgery may spare throat cancer patients from chemo and radiation
- Vaccine trains immune system to fight HPV-Positive head and neck tumors