Comparing two surgical approaches for early oral cavity cancer

Plain-English translation of NCT04333537 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial compares two surgical approaches for treating early-stage oral cavity cancer: a newer, less invasive technique called sentinel lymph node biopsy, and a more traditional approach called elective neck dissection. Both procedures remove lymph nodes in the neck to check for cancer spread, but the newer technique aims to remove fewer lymph nodes while still catching any cancer that may have spread.

Standard neck surgery can cause long-term problems with neck and shoulder movement and function. Researchers want to know if the newer, less invasive technique works just as well at treating cancer while causing fewer of these side effects and improving patients' quality of life.

Do you qualify?

You likely qualify if…

you have been diagnosed with squamous cell carcinoma (a type of cancer) in your oral cavity—such as your tongue, floor of mouth, lips, cheeks, or gums
your cancer is classified as stage I or II (early-stage) with no signs of spread to lymph nodes or distant sites
you have had imaging scans (CT, MRI, ultrasound, or PET/CT) within the past 42 days to confirm your cancer stage
you are at least 18 years old and in good enough overall health to undergo surgery
you can read and understand English or French, since the study uses quality-of-life questionnaires in those languages

You likely don't qualify if…

you have evidence that your cancer has spread to lymph nodes or distant parts of your body
you have had a previous cancer diagnosis (other than non-melanoma skin cancer or certain cervical or breast cancers that were treated effectively)
you are pregnant or planning to become pregnant in the near future
you are not able to undergo surgery or are not a candidate for sentinel lymph node biopsy
you cannot commit to follow-up visits and quality-of-life questionnaires over the study period

What participation looks like

If you join the trial, you'll be randomly assigned to one of two surgical groups. The newer technique group will receive an imaging injection and special scans to identify sentinel lymph nodes before surgery, then undergo the less invasive biopsy. The standard surgery group will undergo traditional neck dissection. Both groups will have imaging scans at screening and during follow-up visits to check for cancer recurrence. You'll also complete questionnaires about your neck and shoulder function at multiple time points over at least 6 months to help researchers understand how each surgery affects your quality of life.

AI-generated summary from trial data · Jun 28, 2026 · Not medical advice

Comparing two surgical approaches for early oral cavity cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(107 sites)