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Radiation for p16+ Oropharynx Cancer

This study is looking at a new way to give radiation therapy for p16-positive (p16+) oropharynx cancer, which is a type of throat cancer. It's for people with favorable risk cancer, meaning it's less likely to spread aggressively. The study uses a special scan called lymphoscintigraphy to guide radiation to your neck. You would receive either 7 weeks of radiation therapy (5 days a week) or 6 weeks of radiation therapy (5 days a week), possibly with the drug Cisplatin. The main goal is to see how many people develop cancer on the opposite side of their neck within 12 months after treatment. This study is currently unclear about its recruitment status and plans to enroll 22 participants.

Study design
This is a Phase II, single-arm study, meaning all participants receive the study treatment. It plans to enroll 22 participants.
What's involved
You would receive radiation therapy for 6-7 weeks. You will also have PET/CT scans and complete questionnaires at 6, 12, and 24 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for disease-free survival and overall survival for up to 24 months after completing treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05800574

Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Fox Chase Cancer Center
~22 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Radiation therapy (5 days for 7 weeks)Radiation therapy (5 days for 6 weeks)Cisplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment
Measured over 1 year

Conditions

Oropharynx Cancer

Explore related trials

Oropharyngeal CarcinomaCDKN2A wt Allele

NCT05800574

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Thomas Galloway, MD · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center

Who to contact

Ryan Romasko
[email protected]
2678388380
Email the study team

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Eligibility criteria

Inclusion

Pathologically confirmed squamous cell carcinoma of the oropharynx
Patients to be treated with bilateral neck radiation per current guidelines must have either present (see below):
Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1\> 1 lymph nodes (on the same side of the neck as the primary cancer) or cN3 (cranial nerve III) with no contralateral neck adenopathy
Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and/or by the treating radiation oncologist or a head and neck surgeon
CT with contrast and/or MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the setting of medical contraindication to both CT and MRI contrast please contact the study PI
PET/CT performed with 28 days prior to registration that does not demonstrate bilateral neck adenopathy.
Immunohistochemical staining for p16 that demonstrates moderate to severe staining in at least 70% of cells.
Patients must provide their smoking history prior to registration. Number of pack-years = \[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\]/20
Patients must have clinically and/or radiographically evident disease that can be accurately measured in accordance with RECIST criteria v. 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 56 days prior to registration
Age ≥ 18 years.
Adequate hematologic function within 14 days prior to registration
Adequate renal function within 14 days prior to registration
Adequate hepatic function within 14 days prior to registration

Exclusion

Tumors that cross midline, regardless of T stage
N2 adenopathy (bilateral neck adenopathy)
Gross total excision of the primary site in a diagnostic procedure prior to either imaging and/or physical examination by registering physician.
p16-negative squamous cell carcinoma
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Prior systemic therapy for the study cancer
Prior head and neck cancer surgery that involved the neck (includes excisional biopsy)
Prior radiation therapy to the head and neck that would result in overlap of treated fields
History of allergic reaction attributed to Technetium-99m-tilmanocept used in lymphoscintigraphy
Uncontrolled intercurrent illness including, but not limited to, any other malignancy, other 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.
Pregnant or breast feeding

What this trial measures

  • Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment1 year

    To evaluate the development of cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment.