This clinical trial looks at two different surgeries for treating early-stage oral cavity cancer. One method is called sentinel lymph node biopsy, which removes fewer lymph nodes using a special imaging agent to find the most likely nodes to have cancer. The other method is called standard neck dissection, which removes more lymph nodes. The goal is to see if the sentinel lymph node biopsy helps patients with their neck and shoulder function and quality of life after surgery.
The trial's ID number is NCT04333537. It is a Phase 2/3 trial, meaning it is looking at how well the treatment works and how safe it is. About 686 people are expected to take part, and this trial is not using any FDA-regulated drugs or devices.
Who can join
This trial is for adults aged 18 and older, both men and women, who have been diagnosed with early-stage squamous cell carcinoma of the oral cavity. Participants must be able to read and understand English or French. Some people may not be eligible, such as those with certain other health conditions or prior cancers. The trial team will confirm who can join.
Conditions
Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma, Gingival Squamous Cell Carcinoma, Hard Palate Squamous Cell Carcinoma, Lip Squamous Cell Carcinoma, Lower Alveolar Ridge Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Retromolar Trigone Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Tongue Squamous Cell Carcinoma, Upper Alveolar Ridge Squamous Cell Carcinoma
Age group
Adult, Older adult
Sex
All sexes
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into two groups by chance. One group will have the sentinel lymph node biopsy, where they will receive an imaging agent and undergo imaging before having the biopsy. The other group will have the standard neck dissection. Everyone will also have imaging tests like FDG PET/CT and chest x-rays during the study.
Where
This trial is running at 106 locations in the United States. 87 of them are currently recruiting.
Avera Cancer Institute
Sioux Falls, South Dakota
Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona
Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona
Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas
Recruiting
Carlisle Regional Cancer Center
Carlisle, Pennsylvania
Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont
Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio
Recruiting
The first 8 of 106 sites are listed here. The registry record has the full list.