Blood test may allow safer radiation for head and neck cancer
NCT ID NCT05962242
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a lower dose of radiation, guided by a blood test that detects HPV DNA from tumors, can safely treat head and neck cancer. About 90 adults with squamous cell carcinoma of the oropharynx will receive reduced radiation to the neck. The goal is to see if this approach controls the cancer as well as standard radiation while causing fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (external beam radiation to head and neck)
- What this could lead to
- If successful, this could lead to a treatment approach that uses lower radiation doses for certain head and neck cancers, potentially reducing side effects while maintaining cancer control.
- What could go wrong
- This is a Phase 2 trial with only 90 participants, so results are preliminary. The lower radiation dose might not control the cancer as well as standard treatment, and there is still a risk of side effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, ≥ 18 years of age 4. Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx of any AJCC 8th edition stage. 5. Eligible for and planning to receive definitive treatment or adjuvant treatment with radiotherapy. 6. Participants who are receiving concurrent systemic anticancer therapy (e.g. chemotherapy or immunotherapy) for oropharyngeal cancer are eligible. 1. For participants with T1-2 and N0 disease, chemotherapy is not required for eligibility. Participants may or may not receive chemotherapy per physician discretion. 2. For participants with T3-4 and/or N+ disease, chemotherapy is required for eligibility. 7. Participants may receive investigational agents with prior approval from the Principal Investigator. 8. ECOG Performance Status of 0-2. 9. p16 positive HPV as determined by NavDx and immunohistochemistry 10. For females of reproductive potential: agreement to use adequate contraception during radiation treatment and for 6 months (or more if applicable based on other medications) after the end of radiation treatment. Exclusion Criteria: 1. Evidence of distant metastatic disease 2. Prior history of radiotherapy to the head and/or neck 3. Had surgery for oropharyngeal cancer within 8 months of enrollment unless it was an incomplete oncologic surgery. Participant is eligible if the gross tumor was not completely removed. 4. Diagnosis of T3-4 and/or N+ disease with no plans to receive concurrent chemotherapy. 5. Diagnosis of a current or prior invasive malignancy (except non-melanoma skin cancer) unless the participant has been disease free for at least 3 years. 6. Participant is a prisoner 7. Known contraindications to head and neck radiation therapy such as ataxia telangiectasia or scleroderma. 8. Pregnancy or lactation 9. Active or severe co-morbidities as defined by the following: 1. Unstable angina and/or congestive heart failure requiring hospitalization up to 180 days before registration 2. Transmural myocardial infarction up to 180 days before registration 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 5. Hepatic insufficiency as determined by the treating clinician resulting in clinical jaundice and/or coagulation effects or severe liver dysfunction. 6. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be slightly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. 10. Tobacco smoking history of 10 pack years or greater, or ≥ 20 pack years if smoking cessation occurred at least 1 year prior to enrollment 11. Current use of antineoplastic drugs for other malignancies.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Bon Secours
NOT_YET_RECRUITINGRichmond, Virginia, 23114, United States
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Eastern Virginia Medical School
NOT_YET_RECRUITINGNorfolk, Virginia, 23507, United States
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Miami Cancer Institute
RECRUITINGMiami, Florida, 33176, United States
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University of Virginia
RECRUITINGCharlottesville, Virginia, 22908, United States
Contact Email: •••••@•••••
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23284, United States
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