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Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT05800574•Fox Chase Cancer Center

View on ClinicalTrials.gov

Summary

Detailed 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

Eligibility

Age

18 - No limit years

Sex

ALL

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
+4 more criteria

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.
+1 more criteria

Locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 14, 2023

Primary Completion Date

September 23, 2025

Completion Date

September 23, 2027

Last Updated

December 24, 2024

Enrollment

ESTIMATED participants

Conditions

Oropharynx Cancer

Interventions

Radiation therapy (5 days for 7 weeks)

RADIATION

Radiation therapy (5 days for 6 weeks)

RADIATION

Cisplatin

DRUG

Contacts

Ryan Romasko

CONTACT

2678388380 ryan.romasko@fccc.edu

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RECRUITINGPHASE2

Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma

Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer