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NRG HN006

Trial Overview

Official Title

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity CancerRandomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Study Purpose

To see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer.

Diagnosis

Patients who have early-stage oral cavity cancer and are having neck dissection surgery.

Eligibility

Early stage SCC T1-2N0 of oral cavity with planned surgery.

PET/CT required.

MUST be node negative.

Excisional biopsies of primary tumor permitted.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

This study has 2 study groups.

  • Group 1: Patients will have the study approach called SLN biopsy surgery.
  • Group 2: Patients will get the usual approach used to treat this type of cancer, END surgery. The END surgery removed many of the lymph nodes in your neck and then tests them for cancer.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase I
Methodist Health System Trial Code
HN006
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