NCT05800574 · Fox Chase Cancer Center
Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
What this study is about
This is a forward-looking, phase II, stratified single treatment group$1 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.
View original scientific description
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.
Interventions
RADIATION
Radiation therapy (5 days for 7 weeks)
Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT)
RADIATION
Radiation therapy (5 days for 6 weeks)
Mon-Fri (5 days for 6 weeks), total 35 fractions over 30 treatment days of RT (two doses 6 hours apart except for the last 6th Friday of the 6 weeks )
DRUG
Cisplatin
Cisplatin, 40mg/m2 (weekly for 7 weeks)
Primary outcome measures
Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment
Time frame: 1 year
To evaluate the development of cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Collaborators
Cardinal Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations