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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

Phase II/III research study to determine how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet with a member of the study team to discuss your treatment or follow-up on previous treatment. The study also involves a blood draw, Multiple FDG PET/CT scans, and the use of oral CT contrast material.

In-person visits:
Around 15

Total length of participation:
About 5 years

Looking for Specific Volunteers

Able to participate:

You have a pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oral cavity
You are age ≥ 18
For women of child bearing potential: you must have a negative serum or urine pregnancy test within 42 days prior to registration
You are able to read and understand English
You have had a surgical assessment within 42 days prior to registration.

Not eligible if:

You have definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease;
You have prior non-head and neck invasive malignancy
You have diagnosis of head and neck SCC in the oropharynx, nasopharynx, hypopharynx, or larynx
You have received prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
You are currently participating in another investigational therapeutic trial

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Trevor Hackman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

23-1131

ClinicalTrials.gov

NCT04333537

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH. This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

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Questions?

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