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

Last updated: December 20, 2024
Sponsor: Fox Chase Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Radiation therapy (5 days for 7 weeks)

Radiation therapy (5 days for 6 weeks)

Cisplatin

Clinical Study ID

NCT05800574
22-1031
HN-107
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Pathologically confirmed squamous cell carcinoma of the oropharynx

  • Patients to be treated with bilateral neck radiation per current guidelines musthave either present (see below):

  • Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8thed.): N0 (provided the tumor is within 1cm of midline) N1> 1 lymph nodes (on thesame side of the neck as the primary cancer) or cN3 (cranial nerve III) with nocontralateral neck adenopathy

  • Tumor stage T1-2 that approaches within 1 cm but does not cross midline asappreciated radiographically and/or by the treating radiation oncologist or a headand neck surgeon

  • CT with contrast and/or MRI with contrast performed within 56 days prior toregistration that does not demonstrate bilateral neck adenopathy. In the setting ofmedical contraindication to both CT and MRI contrast please contact the study PI

  • PET/CT performed with 28 days prior to registration that does not demonstratebilateral neck adenopathy.

  • Immunohistochemical staining for p16 that demonstrates moderate to severe stainingin at least 70% of cells.

  • Patients must provide their smoking history prior to registration. Number ofpack-years = [Frequency of smoking (number of cigarettes per day) x duration ofcigarette smoking (years)]/20

  • Patients must have clinically and/or radiographically evident disease that can beaccurately measured in accordance with RECIST criteria v. 1.1.

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 56days 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

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 eitherimaging and/or physical examination by registering physician.

  • p16-negative squamous cell carcinoma

  • Definitive clinical or radiologic evidence of metastatic disease or adenopathy belowthe clavicles

  • Prior systemic therapy for the study cancer

  • Prior head and neck cancer surgery that involved the neck (includes excisionalbiopsy)

  • Prior radiation therapy to the head and neck that would result in overlap of treatedfields

  • History of allergic reaction attributed to Technetium-99m-tilmanocept used inlymphoscintigraphy

  • Uncontrolled intercurrent illness including, but not limited to, any othermalignancy, other ongoing or active infection, symptomatic congestive heart failure,unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/socialsituations that would limit compliance with study requirements.

  • Pregnant or breast feeding

Study Design

Total Participants: 22
Treatment Group(s): 3
Primary Treatment: Radiation therapy (5 days for 7 weeks)
Phase: 2
Study Start date:
March 14, 2023
Estimated Completion Date:
September 23, 2027

Study 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

Connect with a study center

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

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