Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative

Launched by TATA MEMORIAL HOSPITAL · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two different surgical approaches for treating early-stage mouth cancers that have not spread to the lymph nodes. The trial focuses on understanding which method leads to better survival rates, fewer complications, and is more cost-effective. Participants will be assigned to one of two groups: one group will have a sentinel node biopsy, where doctors check a specific lymph node for cancer and may perform additional surgery if needed. The other group will have a limited neck dissection, where only certain lymph nodes are removed based on whether they show signs of cancer.

To be eligible for this trial, participants must be over 18 years old, have a confirmed diagnosis of early-stage squamous cell carcinoma in the mouth (specifically in the tongue or cheek areas), and show no signs of cancer in the lymph nodes during exams. Patients who have had previous head and neck surgeries or have other specific types of lesions will not be included. Throughout the trial, participants can expect close monitoring and follow-up to understand the outcomes of each surgical approach. This study is currently recruiting participants, and it aims to provide valuable insights that could improve treatment for patients with early oral cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>18 years of age
• • 2. Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa
• • 3. T1 and T2 lesions as per AJCC TNM 8 edition
• • 4. Clinicoradiologically node negative
• • 5. Amenable to per oral excision
• • 6. Treatment naïve
• • 7. No other site of malignancy
• Exclusion Criteria:
• • 1. Previous surgery in the head and neck region,
• • 2. Upper alveolar or palatal lesions
• • 3. Large heterogeneous leukoplakia or other premalignant lesions
• • 4. Previous malignancy in the head and neck region
• • 5. Patients requiring the free flap reconstruction