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

Temple University Health System (TUHS)

Status and phase

Enrolling

Phase 2

Conditions

Oropharynx Cancer

Treatments

Drug: Cisplatin

Radiation: Radiation therapy (5 days for 7 weeks)

Radiation: Radiation therapy (5 days for 6 weeks)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05800574

HN-107 (Other Identifier)

22-1031

Details and patient eligibility

About

Full 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. Patients positive for p16 status will be approached for consent during the pre-treatment intake process. Contralateral neck progression will be measured by PET (positron emission tomography)/CT scans. Xerostomia will be measured by the EORTC QLQ (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) H&N35 at 6, 12, and 24 months. Patients will remain on study treatment for 6-7 weeks or until unacceptable toxicity or withdrawal of consent. Disease free survival (DFS) and overall survival (OS) will be assessed until 24 months after completion of study treatment

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

Cohort A (>N1 or single node > 3cm )

Experimental group

Description:

More extensive neck involvement or proximity to the midline can qualify a patient in cohort A. Cohort A will have patients with either more than one lymph node adenopathy or 1 lymph node that is large (\>3cm).

Treatment: