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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Contact Information
Primary
Ryan Romasko
ryan.romasko@fccc.edu
2678388380
Time Frame
Start Date: 2023-03-14
Estimated Completion Date: 2027-09-23
Participants
Target number of participants: 22
Treatments
Experimental: 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).
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Fox Chase Cancer Center
Collaborators: Cardinal Health

This content was sourced from clinicaltrials.gov