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NCT05800574RecruitingPhase 2

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

A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
22 (estimated)
First submitted
24 Mar 2023
Start date
14 Mar 2023
Primary completion date
23 Mar 2027
Lead sponsor
Fox Chase Cancer Center
NCT number
NCT05800574

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 22
  • From 14 Mar 2023 to the primary completion date, 23 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Gross total excision of the primary site in a diagnostic procedure prior to either imaging and/or physical examination by registering physician.
  • 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

Other illness

  • Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
  • 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.

Other

  • Tumors that cross midline, regardless of T stage
  • N2 adenopathy (bilateral neck adenopathy)
  • p16-negative squamous cell carcinoma
  • Pregnant or breast feeding

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.