Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe… (NCT05774483) | Clinical Trial Compass
RecruitingNot Applicable
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
India508 participantsStarted 2025-04-16
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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