Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek powyżej 21 lat
- •Potwierdzony histologicznie rak płaskonabłonkowy jamy ustnej
- •Zaawansowanie nowotworu T1-T4, bez przerzutów do węzłów i odległych narządów
- •Brak powiększonych węzłów chłonnych w szyi w badaniu klinicznym i tomografii
- •Dobry stan ogólny (klasa ASA I lub II)
- •Zdolność do zrozumienia badania i wyrażenia świadomej zgody
✗ Disqualifies
- •Wznowa choroby (nawrót raka)
- •Potwierdzony pozytywny wynik biopsji węzłów chłonnych szyi
- •Poprzednia radioterapia głowy i szyi
- •Poprzednia operacja szyi lub radioterapia
- •Historia jakiegokolwiek nowotworu w przeszłości
Simplified criteria — AI translation
Trial details
- Minimum age
- 21 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Kolhapur Cancer Centre- Cancer Centers of America
Kolhāpur, India
Trial contact
Maroti B Wadewale, MDS, FHNO
Parag J Watve, MS, FHNS
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/26/2026.
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