Clinical Trial Finder

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

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.

Arms

Active Comparator: Sentinel node biopsy

Experimental: Limited elective neck dissection

Interventions

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.