De-Escalated Radiation Therapy for HPV-Positive Oropharyngeal Cancer
This study is looking at new ways to tailor radiation therapy for people with HPV-positive oropharyngeal (throat) cancer. Researchers are using blood and saliva tests (NavDx) to measure HPV DNA, along with other factors, to decide the best treatment intensity. The study is testing different radiation approaches, including Diffusing Alpha-emitter Radiation Therapy (DART), and chemotherapy drugs like cisplatin and docetaxel. The goal is to see if these tailored treatments can effectively control the cancer while potentially reducing side effects. The study aims to enroll 455 participants and is currently recruiting. Success will be measured by how long people live without their cancer progressing (progression-free survival) for up to 5 years.
- Study design
- This is an interventional study with a planned enrollment of 455 participants. It is exploring different treatment approaches based on individual risk factors.
- What's involved
- You would undergo blood and saliva collection for NavDx testing, CT scans, and receive either radiation therapy (DART) or chemotherapy (cisplatin or docetaxel).
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed to track progression-free survival for up to 5 years after registration.
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NCT05541016
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~455 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCisplatinComputed TomographyDiffusing Alpha-emitter Radiation TherapyDocetaxelIntensity-Modulated Proton Therapy
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over From registration to the first of either disease progression/recurrence or death, assessed up to 5 years
Conditions
Where it's being run
3 sites across 3 statesArizona1
Florida1
Minnesota1
Study leadership
- David M, Routman, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
PRE-REGISTRATION (optional): Provide written informed consent
Age \>= 18 years
Histological confirmation of squamous cell carcinoma originating from or suspected to be originating from the oropharynx
Plan for gross total surgical resection via trans oral surgery with curative intent and at least unilateral neck dissection OR chemoradiotherapy with cisplatin. Note: The patient must be cisplatin eligible even if an alternate is used due to drug shortage
Absence of distant metastases on standard diagnostic work-up =\< 16 weeks prior to registration. (Chest CT or PET/CT)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 1
Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
Ability to complete questionnaire(s) by themselves or with assistance
Provide written informed consent
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Willing to provide blood samples for correlative research purposes, including anonymous shipment of samples to for NavDx testing
Exclusion
Any of the following:
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)+
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
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy =\< 5 years prior to registration. EXCEPTIONS: Nonmelanotic skin cancer or carcinoma-in-situ of the cervix, or prostate or localized endometrioid endometrial cancer. NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
Prior history of radiation therapy to the affected site
Prior systemic chemotherapy in the last 5 years
Contraindication to radiation therapy as determined by the treating team
History of allergic reaction to docetaxel
Receiving any medications or substances which in the opinion of the investigators would interfere with treatment. Examples could include strong inhibitors of cytochrome P450 3A4 (CYP3A4) at oncologist discretion
Severe pre-existing ototoxicity or neuropathy that would, in the opinion of the investigator, preclude the use of cisplatin chemotherapy
cT4 primary tumor
NOTE: Patients with no intermediate risk factors after surgery, low risk patients, as defined by T1, T2, tumors with lymph node less than 3cm, no intermediate or high-risk factors such as lymphatic invasion (LVSI), extranodal extension (ENE), perineural invasion (PNI), positive margin, will be withdrawn from study and be observed per current clinical standard of care. Patients found to be both HPV negative and p16 negative will be withdrawn from study.
Patients found to have HPV non 16 type, or HPV detectability in blood less than \<20tumor tissue modified viral (TTMV) will not be candidates for de-escalation in Groups 1 and 2 and will be treated in Group 3 unless otherwise meeting criteria for low risk. They will receive 60 Gy +/- cisplatin or acceptable alternate regimen when drug shortages of cisplatin exist. If treated primarily with chemoradiation (chemoRT) (Group 4), these patients will not be candidates for de-escalation if TTMV is \< 50 TTMV but can remain on study receiving 70 Gy with all corresponding correlative studies applying
Patients with unknown (radiologic/clinically occult) primaries but neck adenopathy suspected to be HPV associated oropharyngeal carcinoma can be registered to go on study for Groups 1-3. Should after primary resection, no primary tumor be identified, the patient will be withdrawn from study and be treated per institutional standard of care. Group 4 patients must have an identifiable (clinically or radiologically apparent) primary tumor
All treatment primarily, including surgery and chemotherapy will be performed at the enrolling institution
What this trial measures
- Progression-free survival (PFS)From registration to the first of either disease progression/recurrence or death, assessed up to 5 years
Progression-free survival (PFS), the time from treatment initiation until disease progression or worsening. PFS at specific timepoints will be estimated using Kaplan-Meier methodology.