NCT05774483

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 508 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Based on the current literature, we know that elective neck dissection (END) is mandatory in clinically node-negative early oral cancers. However, this leads to overtreatment and morbidity in about 55-80% of patients. The emergence of recent level I evidence makes SNB the standard of care in this setting. However, its limitation of being a two-staged procedure, steep learning curve, the burden on resources, lack of infrastructure, short-lasting decrease in morbidity and lack of cost-effectiveness data limits its wide applicability. It is our routine departmental practice of performing limited neck dissection clearing level I-III/IV sparing level IIb which is cleared only if level IIa is metastatic. It is hypothesized that limited END would limit the morbidity of shoulder dysfunction and be a more feasible and cost-effective treatment option which could be a suitable alternative to SNB in this setting without compromising the survival outcomes. With this background, we propose to embark upon a phase III RCT comparing the oncologic outcomes and morbidity of SNB versus limited END. We hypothesize that limited END would have survival outcomes non-inferior, morbidity similar to SNB with higher cost-effectiveness. Aims and objectives: Aim To compare the survival outcomes, morbidity and cost-effectiveness of SNB versus limited END in node-negative early oral cancers Primary objective 1\) Overall survival Secondary objectives 1. Shoulder morbidity (key secondary endpoint) longitudinally up to 2 years 2. Disease-free survival 3. Neck nodal recurrence-free survival 4. Other side effects (chyle leak, hematoma, lymphoedema) 5. Longitudinal Quality of life up to 2 years 6. Cost-effective analysis Exploratory objectives Blood and tumour tissue will be collected and banked for biomarker studies. Exploratory analyses will be conducted at a later date. Efforts may be directed to identify the biomarkers to predict nodal metastasis.

Conditions

• Mouth Neoplasms
• Oral Cancers
• Oral Squamous Cell Carcinoma (OSCC)
• Oral Squamous Cell Carcinomas
• Sentinel Lymph Node Biopsy
• Sentinel Lymph Node Biopsy (SLNB)
• Sentinel Lymph Node

Interventions

Type	Name	Description
PROCEDURE	Sentinel 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.
PROCEDURE	Limited 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.

Timeline

• Start date: 2025-04-16
• Primary completion: 2032-04-01
• Completion: 2034-04-01
• First posted: 2023-03-17
• Last updated: 2025-07-17

Locations

3 sites across 1 country: India