Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With 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
Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. While modified neck dissection (MND, levels I-V) is widely practiced, selective neck dissection (SND, levels I-IV) may provide equivalent oncologic outcomes with reduced surgical morbidity. However, high-quality randomized evidence comparing these approaches is lacking. The ExteNT N1 Trial is a prospective, randomized, open-label, parallel-group clinical trial designed to compare selective neck dissection (levels I-IV) with modified neck dissection (levels I-V, preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle) in patients with resectable cN1 oral cavity squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to either treatment arm. The primary endpoint is 3-year regional recurrence-free survival (RRFS), along with postoperative quality of life measured using the Neck Dissection Impairment Index (NDII). Secondary endpoints include overall survival, disease-free survival, level-wise nodal involvement, nodal yield, shoulder function (Constant-Murley Score, SPADI, and Arm Abduction Score), postoperative complications including chyle leak, and other surgical morbidities. This trial aims to generate level I evidence regarding the optimal extent of neck dissection for cN1 OCSCC, balancing oncologic safety with preservation of postoperative function and quality of life.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rozpoznaniem histologicznym rak płaskonabłonkowy jamy ustnej
- •Nowotw jednego węzła chłonnego potwierdzony biopsją bez innych podejrzanych węzłów
- •Ogólny stan zdrowia pacjenta oceniony jako I lub II w skali ASA
- •Pacjent rozumie plan badania i wyraza zgodę na uczestnictwo
✗ Disqualifies
- •Pacjenci z nawrotem raka
- •Pacjenci z wieloma podejrzanymi węzłami chłonnymi
- •Węzły chłonne z przerostem poza kapsułę
- •Jeden węzeł w lokalizacji III, IV lub V
- •Historia wcześniejszej radioterapii szyi lub głowy
- •Historia innego nowotworu złośliwego w przeszłości
Simplified criteria — AI translation
Trial details
- Minimum age
- 21 Years
- Maximum age
- 75 Years
- Last updated (source)
- August 4, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Kolhapur Cancer Centre
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: 8/5/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.