A Study Comparing Sentinel Lymph Node Biopsy with Standard Neck Lymph Node Removal in People with Early-Stage Oral Cavity Cancer


Full Title

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer (NRG-HN006) (CIRB)


Researchers in this study want to compare sentinel lymph node biopsy surgery with standard neck dissection as part of the treatment for people with early-stage oral cavity (mouth) cancer. Sentinel lymph node biopsy is a procedure that removes a smaller number of lymph nodes from the neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard elective neck dissection removes many of the lymph nodes in the neck but may reduce shoulder mobility and strength.

In this study, patients with squamous cell carcinoma of the oral cavity whose PET/CT scans do not show evidence of cancer spread will be randomly assigned to have either sentinel lymph node biopsy or elective neck dissection. Investigators will also compare quality of life and shoulder function between the two groups.

Who Can Join

To be eligible for this study, patients must meet several requirements, including but not limited to:

  • Participants must have squamous cell carcinoma of the oral cavity that has not spread beyond the mouth.
  • Prior surgery, chemotherapy, or radiation therapy for oral cavity cancer is not permitted.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.


For more information about this study and to ask about eligibility, please contact the office of Dr. Jennifer Cracchiolo at 646-497-9161.




Phase II/III (phases 2 and 3 combined)

Disease Status

Newly Diagnosed



ClinicalTrials.gov ID