Targeted radiation therapy for p16+ oropharynx cancer
A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation
This study is testing a targeted radiation therapy for patients with a specific type of throat cancer to see if it helps them live longer and feel better after treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fox Chase Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05800574 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the effectiveness of lymphoscintigraphy directed elective neck radiation in patients with favorable prognosis p16+ oropharynx cancer. The study focuses on patients with either node negative or malignant neck adenopathy, utilizing a stratified single arm approach. Participants will undergo radiation therapy for 6-7 weeks, with disease-free survival and overall survival monitored for up to 24 months post-treatment. Quality of life will also be assessed through standardized questionnaires at multiple time points.
Who should consider this trial
Good fit: Ideal candidates are patients with pathologically confirmed squamous cell carcinoma of the oropharynx who are p16 positive and meet specific nodal status criteria.
Not a fit: Patients with bilateral neck adenopathy or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with p16+ oropharynx cancer.
How similar studies have performed: Other studies have shown promising results with targeted radiation approaches in similar patient populations, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Galloway, MD — Fox Chase Cancer Center
- Study coordinator: Ryan Romasko
- Email: ryan.romasko@fccc.edu
- Phone: 2678388380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.