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

RecruitingNAAges 18 Years - 80 YearsAllTata Memorial Hospital
NCT05774483 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Sentinel Node Biopsy
  • Limited Elective Neck Dissection
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Where

3 sites
Tata Memorial Hospital
Mumbai, India
ACTREC
Navi Mumbai, India
Mpmmcc & Hbch
Varanasi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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