Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
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.
Conditions:
🦠 Oropharynx Cancer
🗓️ Study Start (Actual) 14 March 2023
🗓️ Primary Completion (Estimated) 23 September 2024
✅ Study Completion (Estimated) 23 September 2026
👥 Enrollment (Estimated) 22
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 March 2023
  • First Submitted that Met QC Criteria 24 March 2023
  • First Posted 5 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 April 2024
  • Last Update Posted 9 April 2024
  • Last Verified April 2024