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Sentinel Lymph Node Biopsy vs Neck Dissection for Oral Cancer

Phase 2 & 3

Recruiting

Led By Stephen Y Lai

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgical resection of the primary tumor through a transoral approach

Pathologically proven diagnosis of squamous cell carcinoma of specific oral cavity sites

Must not have

Prior surgery involving the lateral neck

Definitive evidence of regional and/or distant metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death due to any cause, assessed up to 11 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares sentinel lymph node biopsy surgery to standard neck dissection for early-stage oral cavity cancer.

Who is the study for?

This trial is for adults with early-stage oral cavity cancer, including cancers of the tongue, floor of mouth, and other areas within the oral cavity. They must be candidates for surgery through a transoral approach and have no evidence of distant metastatic disease. Pregnant or breastfeeding women are excluded, as well as those with severe co-morbidities or who have had certain prior treatments.

What is being tested?

The study compares sentinel lymph node biopsy (SLNB) to standard neck dissection in treating early-stage oral cavity cancer. SLNB uses an imaging agent to identify key lymph nodes for removal, potentially offering a less extensive surgery than traditional neck dissection which removes many lymph nodes.

What are the potential side effects?

Potential side effects may include pain and swelling at the surgical site, risk of infection, nerve damage leading to numbness or weakness, difficulty swallowing if nerves affecting muscles are impacted, and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My primary tumor was removed through my mouth.

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I have been diagnosed with squamous cell carcinoma in my mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on the side of my neck.

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My cancer has spread to other parts of my body.

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My cancer is in my head or neck.

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I cannot or do not want to complete the NDII questionnaire.

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I have had cancer other than in the head or neck area in the last 2 years.

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I have had radiation therapy on the cancer area being studied.

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I have a serious health condition that prevents neck surgery.

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I have a history of blood cancer.

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I am currently on specific medical treatments.

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I have received chemotherapy for my current cancer.

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My oral surgery didn't remove all cancer, and cancer cells were found at the edge of the removed tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death due to any cause, assessed up to 11 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death due to any cause, assessed up to 11 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death due to any cause, assessed up to 11 years for reporting.