Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
NCT ID: NCT05800574
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
22 participants
INTERVENTIONAL
2023-03-14
2027-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A (>N1 or single node > 3cm )
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).
Radiation therapy (5 days for 7 weeks)
Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT)
Cisplatin
Cisplatin, 40mg/m2 (weekly for 7 weeks)
Cohort B (N0 or N1 <3cm)
For Cohort B patients need to have either no lymph nodes or only one lymph node adenopathy, provided it is smaller than 3cm.
Radiation therapy (5 days for 6 weeks)
Mon-Fri (5 days for 6 weeks), total 35 fractions over 30 treatment days of RT (two doses 6 hours apart except for the last 6th Friday of the 6 weeks )
Interventions
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Radiation therapy (5 days for 7 weeks)
Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT)
Radiation therapy (5 days for 6 weeks)
Mon-Fri (5 days for 6 weeks), total 35 fractions over 30 treatment days of RT (two doses 6 hours apart except for the last 6th Friday of the 6 weeks )
Cisplatin
Cisplatin, 40mg/m2 (weekly for 7 weeks)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cardinal Health
INDUSTRY
Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Thomas Galloway, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Thomas Galloway, MD
Role: primary
Other Identifiers
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HN-107
Identifier Type: OTHER
Identifier Source: secondary_id
22-1031
Identifier Type: -
Identifier Source: org_study_id