RecruitingPhase 2NCT05800574

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

A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation

Sponsor

Fox Chase Cancer Center

Enrollment

22 participants

Start Date

Mar 14, 2023

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria14

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 Criteria11

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

Interventions

RADIATIONRadiation therapy (5 days for 7 weeks)

Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT)

RADIATIONRadiation 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 )

DRUGCisplatin

Cisplatin, 40mg/m2 (weekly for 7 weeks)