RecruitingNot ApplicableNCT05774483

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

Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial


Sponsor

Tata Memorial Hospital

Enrollment

508 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers. The main questions it aims to answer are: * Survival outcomes * Morbidity outcomes * Cost-effectiveness Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two surgical approaches for early-stage tongue or cheek cancer (oral squamous cell carcinoma) where the lymph nodes in the neck appear cancer-free. One approach uses a sentinel node biopsy (a minimally invasive technique to check if cancer has spread to nearby lymph nodes), while the other removes a small group of neck lymph nodes as a precaution (limited elective neck dissection). **You may be eligible if...** - You are over 18 with biopsy-confirmed squamous cell carcinoma of the tongue or inner cheek - Your cancer is early stage (T1 or T2) with no detectable lymph node involvement on imaging or exam - The tumor can be removed through the mouth (per oral excision) - You have not had any prior treatment for this cancer **You may NOT be eligible if...** - You have had previous head and neck surgery or cancer - Your tumor is on the upper gum or palate - You have other cancers - You would need a large tissue flap reconstruction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESentinel Node Biopsy

The Sentinel node will be localized after injecting peritumoral nano colloid followed by dynamic lymphoscintigraphy and SPECT localization. Methylene blue or indocyanine green may be used but not mandatory as an adjunct for lymphoscintigraphy for node localization. Intraoperatively the node will be identified using a hand-held gamma probe. The sentinel node will be processed on a frozen section, histopathological processing with serial step sectioning, and immunohistochemistry. If reported as metastatic, then a single-stage or second-stage completion neck dissection will be performed.

PROCEDURELimited Elective Neck Dissection

Patients who are allocated to the limited END arm will undergo dissection of level I, IIa and III/IV nodes sparing level IIb. Level IIa will be subjected to a frozen section and if reported as metastatic will mandate clearance of level IIb.


Locations(3)

Tata Memorial Hospital

Mumbai, Maharashtra, India

ACTREC

Navi Mumbai, Maharashtra, India

Mpmmcc & Hbch

Varanasi, Uttar Pradesh, India

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NCT05774483


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