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

Launched by FOX CHASE CANCER CENTER · Mar 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat patients with a type of throat cancer known as p16+ oropharynx cancer. The focus is on using a specific type of imaging called lymphoscintigraphy to guide radiation therapy for patients who have a favorable prognosis, meaning their cancer is less aggressive. The trial is looking for participants aged 18 and older who have been diagnosed with squamous cell carcinoma of the oropharynx and meet certain criteria, such as having no significant spread of cancer to both sides of the neck and specific tumor characteristics.

Participants in this trial can expect to receive targeted radiation therapy based on their lymphoscintigraphy results. This means that the treatment will be more precisely directed to the affected areas, which may help improve outcomes. It's important to note that candidates cannot have tumors that spread across the center of the neck or have certain other health conditions. If you or a loved one has been diagnosed with this type of cancer, this trial could provide an opportunity for a tailored treatment approach, and the research team will ensure you understand all aspects of participation.

Gender

ALL

Eligibility criteria

• 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