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
Tata Memorial Hospital
508 participants
Apr 16, 2025
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
Inclusion Criteria7
- Age \>18 years of age
- Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa
- T1 and T2 lesions as per AJCC TNM 8 edition
- Clinicoradiologically node negative
- Amenable to per oral excision
- Treatment naïve
- No other site of malignancy
Exclusion Criteria5
- Previous surgery in the head and neck region,
- Upper alveolar or palatal lesions
- Large heterogeneous leukoplakia or other premalignant lesions
- Previous malignancy in the head and neck region
- Patients requiring the free flap reconstruction
Interventions
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.
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)
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NCT05774483