Actively Recruiting
Led by Tata Memorial Hospital · Updated on 2025-07-17
508
Participants Needed
3
Research Sites
104 weeks
Total Duration
T
Tata Memorial Hospital
Lead Sponsor
T
Tata Memorial Centre
Collaborating Sponsor
Researchers are evaluating the outcomes of sentinel node biopsy compared to limited elective neck dissection in patients with early-stage oral cancers that have no clinical evidence of lymph node involvement. The study aims to compare survival rates, side effects, and cost-effectiveness between these two surgical approaches. This phase III randomized trial also explores the impact on shoulder function and quality of life over time, while collecting tissue samples for future biomarker research. Participants are assigned to one of two groups: one undergoes sentinel node biopsy with potential completion neck dissection if cancer is found in the sentinel node, while the other receives limited elective neck dissection removing certain lymph node levels, sparing others unless metastasis is detected. The limited dissection aims to reduce shoulder morbidity and healthcare costs. Both procedures are surgical interventions performed according to specific protocols. During the study, participants will be monitored for overall survival and disease recurrence over three years. Researchers will assess shoulder function, quality of life, and surgery-related side effects at multiple time points up to two years. Cost-effectiveness will also be analyzed. Tissue and blood samples will be collected for additional studies. The total follow-up period includes regular evaluations to understand long-term effects and treatment outcomes.
CONDITIONS
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with possible second-stage completion neck dissection if metastasis is found
Participants undergo either sentinel node biopsy or limited elective neck dissection to treat early oral cavity cancer.
1 to 2 surgical visits depending on pathology results
Duration - Up to 3 years
Participants are monitored for shoulder morbidity, neck nodal recurrence, quality of life, adverse events, and overall survival for up to 3 years after treatment.
Visits at preoperative baseline, 3, 6, 12, 24 months, and annual assessments up to 3 years
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
R
Richa Vaish, MS, M.Ch
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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