RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-14

Study Completion:2026-09-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05800574

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Ryan Romasko

CONTACT

2678388380

ryan.romasko@fccc.edu

Principal Investigator

Thomas Galloway, MD

PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

Thomas Galloway, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14

Study Completion Date2026-09-23

Study Record Updates

Study Start Date2023-03-14

Study Completion Date2026-09-23

Terms related to this study

Additional Relevant MeSH Terms

Oropharynx Cancer