Actively Recruiting
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
Led by Tata Memorial Hospital · Updated on 2025-07-17
508
Participants Needed
3
Research Sites
467 weeks
Total Duration
On this page
Sponsors
T
Tata Memorial Hospital
Lead Sponsor
T
Tata Memorial Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Biopsy-confirmed invasive squamous cell carcinoma of the tongue or buccal mucosa
- Tumor classified as T1 or T2 stage according to AJCC TNM 8th edition
- No clinical or radiological evidence of lymph node involvement
- Tumor suitable for removal through the mouth
- No previous treatment for this cancer
- No other known cancer sites
You will not qualify if you...
- Previous surgery in the head and neck area
- Cancer located in the upper alveolar ridge or palate
- Presence of large or mixed leukoplakia or other premalignant lesions
- History of prior head and neck cancer
- Need for free flap reconstruction surgery
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
2
ACTREC
Navi Mumbai, Maharashtra, India
Not Yet Recruiting
3
Mpmmcc & Hbch
Varanasi, Uttar Pradesh, India
Not Yet Recruiting
Research Team
R
Richa Vaish, MS, M.Ch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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