Can less radiation be just as good for HPV throat cancer?
NCT ID NCT05119036
First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This study looks at whether giving less radiation after surgery for HPV-positive throat cancer can still prevent the cancer from coming back while causing fewer long-term side effects. About 83 adults with HPV-positive oropharyngeal cancer will receive either a standard or reduced radiation dose to the surgical area. The goal is to see if the lower dose works as well as the usual treatment.
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
- What this could lead to
- If successful, this could show that a lower dose of radiation after surgery is just as effective as standard treatment, reducing long-term side effects for patients.
- What could go wrong
- This is a small, early-phase study with only 83 participants, so results may not apply to everyone. Reducing radiation might increase the risk of cancer returning.
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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82 people
The number who actually took part.
- Started
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May 2022
- Finished
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Jul 2026
- 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * Subjects ≥ 18 years old at the time of informed consent. * Ability to provide written informed consent and HIPAA authorization. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (refer to Appendix). * Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx). * Histopathologically confirmed squamous cell carcinoma. * HPV+ tumor, as determined by p16, in-situ hybridization, or real-time polymerase chain reaction. * Note: If patients present who have unconfirmed p16/HPV positive disease but have clinical findings that indicate a high probability of HPV positive disease, these patients can be deemed eligible after testing is performed at post-surgery. * Resectable and accessible tumor with high probability of achieving negative margins. * Smokers and non-smokers included. * Tumor stage (AJCC 8th edition): T1 or T2. * Nodal stage (AJCC 8th edition): N0, N1 or N2. * Mobile neck nodes on physical exam if N positive. * Subjects with synchronous primaries included. * Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary. Exclusion Criteria: * Serious medical condition preventing general anesthesia for surgery. * Inability to complete full course of radiation treatment or attend follow-up visits. * History of previous head and neck radiation or previous head and neck cancer within 3 years. * Distant metastatic disease present. * Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study. * Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test within 60 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless the patients meet one of the following criteria: 1. Has undergone a hysterectomy or bilateral oophorectomy; or 2. Has been naturally amenorrheic for at least 24 consecutive months.
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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.
Contacts and locations
Locations
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IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032, United States
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Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
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Other studies related to the condition(s) this trial covers.
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