Could less radiation be enough for HPV throat cancer?
NCT ID NCT06554158
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for people with HPV-positive oropharyngeal (throat) cancer who have had surgery. Researchers want to see if giving a lower dose of radiation to a smaller area (just the neck, not the original tumor site) works as well as the standard higher dose. The goal is to reduce side effects while still controlling the cancer. About 30 participants will receive this de-escalated radiation therapy and be followed for two years.
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 (lower dose, smaller field)
- What this could lead to
- If successful, this could allow many patients with HPV-positive throat cancer to receive less radiation, reducing long-term side effects like swallowing problems and dry mouth.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply to everyone. There is a risk that lower-dose radiation might not control the cancer as well as standard treatment.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2019
- Expected to finish
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Dec 2028
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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Accepted
You do not need to have the condition being studied to take part.
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: * Patients must be ≥ 18 years of age on the day of signing informed consent. * Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall). * pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site. * Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration. * neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration. * hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal. * current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history * start radiation within 8 weeks of resection (6 weeks preferable) * have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: * Perineural invasion at primary site * Lymphovascular space invasion at primary site * Level 4 nodal involvement (even if resected) * Retropharyngeal nodal involvement (even if resected) * any intact, unresected disease * nodal disease pathologically invading adjacent neck musculature * Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy * Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance. * Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma
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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 places running it
1 site. 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
Locations
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Medstar Georgetown University Hospital
RECRUITINGWashington D.C., District of Columbia, 20007, 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?
- Can a shorter, targeted radiation course tame throat cancer?
- MRI-Guided tweaks during radiation could spare throat cancer patients from swallowing woes
- Can a more intense radiation schedule outperform Chemo-Radiation for head and neck cancer?
- Can less radiation be safer for throat cancer?