Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread
Recruiting now · Not applicable
Conditions studied: Oral Squamous Cell Carcinoma (OSCC)
In brief
The goal of this clinical trial is to learn whether selective neck dissection involving lymph node levels I-III is as effective as selective neck dissection involving levels I-IV in treating adults with clinically node-negative (cN0) oral squamous cell carcinoma undergoing curative surgery. It will also evaluate whether extending the neck dissection to level IV affects cancer control, surgical complications, shoulder function, and quality of life. The main questions it aims to answer are: * Does selective neck dissection of levels I-III provide regional recurrence-free survival comparable to selective neck dissection of levels I-IV? * Does extending the neck dissection to level IV improve overall survival, disease-free survival, or reduce regional recurrence? * Does selective neck dissection of levels I-III result in less postoperative morbidity, better shoulder function, and improved quality of life compared with selective neck dissection of levels I-IV? Researchers will compare patients undergoing selective neck dissection of levels I-III with those undergoing selective neck dissection of levels I-IV to determine whether routine removal of level IV lymph nodes provides additional oncological benefit while maintaining acceptable functional outcomes. Participants will: * Undergo surgery for oral squamous cell carcinoma with random assignment to selective neck dissection of either levels I-III or levels I-IV. * Receive standard postoperative treatment, including radiotherapy or chemoradiotherapy when indicated according to the final pathology report. * Attend scheduled follow-up visits for clinical examinations and surveillance for cancer recurrence. * Undergo assessments of shoulder function, sensory function, postoperative complications, and quality of life using validated questionnaires at predefined follow-up intervals.
Key facts
- Study ID
- NCT07726199
- Run by
- Kolhapur Cancer Centre - Cancer Centers of America
- People needed
- 267
- Starts
- 2026-04-22
- Expected to finish
- 2030-09-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged over 21 years will be included.
- Histologically proven squamous cell carcinoma of oral cavity will be included
- Clinical stage T1-T4, N0, M0
- cN0 neck on clinical examination and imaging (CT/MRI)
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Understands the protocol
- and can give informed consent.
You may not qualify if…
- Recurrent cases
- FNAC proven Positive cervical nodes
- Patients with history of head and neck radiation therapy treatment
- Previous neck surgery or radiotherapy
- Previous history of any cancer
Where it is running
- Kolhapur Cancer Centre- Cancer Centers of America — Kolhāpur, Maharashtra, India (enrolling)
Full record on ClinicalTrials.gov
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