Actively Recruiting
Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
Led by Fox Chase Cancer Center · Updated on 2024-12-24
22
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
C
Cardinal Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous cell carcinoma of the oropharynx
- Patients planned for bilateral neck radiation per guidelines must have either no nodes or limited nodes on the same side without contralateral neck adenopathy
- Tumor stage T1-2 approaching within 1 cm but not crossing the midline
- CT or MRI with contrast within 56 days before enrollment showing no bilateral neck adenopathy
- PET/CT within 28 days before enrollment showing no bilateral neck adenopathy
- p16 staining showing moderate to severe staining in at least 70% of cells
- Smoking history provided before enrollment
- Clinically or radiographically measurable disease per RECIST v1.1
- ECOG performance status 0-1 within 56 days before enrollment
- Age 18 years or older
- Adequate blood, kidney, and liver function within 14 days before enrollment
You will not qualify if you...
- Tumors crossing the midline at any T stage
- Bilateral neck adenopathy (N2)
- Complete removal of primary site before imaging or exam by registering physician
- p16-negative squamous cell carcinoma
- Clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
- Prior systemic therapy for this cancer
- Prior head and neck surgery involving the neck
- Prior radiation to the head and neck overlapping study fields
- Allergy to Technetium-99m-tilmanocept
- Uncontrolled illnesses including other cancers, active infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
R
Ryan Romasko
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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