Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
ConditionOropharynx Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center
About this trial
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
Qualifiers
Pathologically confirmed squamous cell carcinoma of the oropharynx
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Radiation therapy (5 days for 7 weeks)
- Radiation therapy (5 days for 6 weeks)
- Cisplatin
Treatment groups
22 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fox Chase Cancer Center
Lead sponsor
Cardinal Health
Collaborator
Source ClinicalTrials.gov