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

Study Summary

“Thomas J. Galloway, MD

This is a prospective, phase II, 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 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. Patients who show low risk for developing contralateral cancer will be assigned to experimental cohorts: cohort A or cohort B depending on their disease status, radiology reports and as per treating physician's discretion. 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). For Cohort B patients need to have either no lymph nodes or only one lymph node adenopathy, provided it is smaller than 3cm The accrual goal is 22 patients

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About This Trial:

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515. or fill out this form.

Protocol:
22-1031 / IRB22-1031

Phase:
II

Investigator:
Thomas J. Galloway, MD

Disease(s):
Lip, Oral Cavity and Pharynx

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

Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Inclusion Criteria:

    Pathologically confirmed squamous cell carcinoma of the oropharynx Patients to be treated with bilateral neck radiation per current guidelines must have either Nodal status (based on staging manual, AJCC 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 with no contralateral neck adenopathy or 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

Exclusion Criteria:

    Tumors that cross midline, regardless of T stage N2 adenopathy (bilateral neck adenopathy) p16-negative squamous cell carcinoma

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515.