Comparing Two Neck Surgery Extents in Oral Cancer Without Visible Neck Spread
Compares removing fewer or more neck lymph nodes in adults with oral squamous cell carcinoma.
Plain-language title generated from the registry record
Registry title: Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread
Key facts
- Where
- Kolhāpur, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 75 years old?
Source: NCT07726199, who can take part
Where in India
- Kolhapur Cancer Centre- Cancer Centers of AmericaKolhāpur, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kolhapur Cancer Centre - Cancer Centers of America
- Trial code
- NCT07726199
- Record updated
- 4 August 2026
- Original description
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:Read full original descriptionShow less
ExteNT N0 Trial- Extent of Neck Treatment in Clinically N0 Oral Cancer: A Randomized Controlled Trial
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.
Inclusion: 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.
Exclusion: Previous neck surgery or radiotherapy; Previous history of any cancer; Patients with history of head and neck radiation therapy treatment; Recurrent cases; FNAC proven Positive cervical nodes.