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Taking people in United StatesPhase 2

Radiation Targeting Neck Lymph Nodes in Throat Cancer Patients

Tests neck radiation guided by lymph node mapping in adults with p16-positive oropharynx cancer.

Key facts

Who runs it
Fox Chase Cancer Center
Where
Philadelphia, United StatesSee the site
Trial code
Registry title
Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
Status
Recruiting
Phase
Phase 2
People taking part
22 people, planned
Started
14 Mar 2023
Expected to end
23 Sept 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Radiation therapy (5 days for 7 weeks)
  • Radiation therapy (5 days for 6 weeks)
  • Cisplatin
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with p16-positive squamous cell cancer of the oropharynx (throat) who will have radiation to both sides of the neck, with no cancer in the neck lymph nodes on both sides.

Age
18 years or older
Sex
All sexes can join
Disease stage
Squamous cell carcinoma of the oropharynx. Tumor stage T1-2 that does not cross the midline. Lymph nodes either clear (N0, tumor within 1 cm (0.4 in) of midline) or affected on the same side as the tumor only. No swollen lymph nodes on both sides of the neck. Disease must be measurable by RECIST v. 1.1.
Earlier treatment
No earlier systemic therapy for this cancer. No earlier head and neck cancer surgery involving the neck. No earlier head and neck radiation that would overlap the treated area.
Biomarker or test result
p16 staining of moderate to severe strength in at least 70% of cells. Smoking history must be given before registration.

Main reasons for not taking part

  • Tumor crossing the midline
  • Swollen lymph nodes on both sides of the neck (N2)
  • p16-negative cancer
  • Metastatic disease or lymph nodes below the collarbones
  • Pregnant or breast feeding

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

  • Fox Chase Cancer CenterPhiladelphia, United StatesContact: Thomas Galloway, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Cohort A (>N1 or single node > 3cm )Treatment being tested

    More extensive neck involvement or proximity to the midline can qualify a patient in cohort A. Cohort A will have patients with either more than one lymph node adenopathy or 1 lymph node that is large (\>3cm).

    Treatment: Radiation therapy (5 days for 7 weeks) and Cisplatin

  • Cohort B (N0 or N1 <3cm)Treatment being tested

    For Cohort B patients need to have either no lymph nodes or only one lymph node adenopathy, provided it is smaller than 3cm.

    Treatment: Radiation therapy (5 days for 6 weeks)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation
Plain-language title
Radiation Targeting Neck Lymph Nodes in Throat Cancer PatientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 November 2026