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NCT07726199Recruiting

Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread

ExteNT N0 Trial- Extent of Neck Treatment in Clinically N0 Oral Cancer: A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 4 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
267 (estimated)
First submitted
9 Jul 2026
Start date
22 Apr 2026
Primary completion date
1 Sept 2030
Lead sponsor
Kolhapur Cancer Centre - Cancer Centers of America
NCT number
NCT07726199

What you commit to

  • Study type: Interventional
  • Planned participants: 267
  • From 22 Apr 2026 to the primary completion date, 1 Sept 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous neck surgery or radiotherapy
  • Previous history of any cancer

Other illness

  • Patients with history of head and neck radiation therapy treatment

Other

  • Recurrent cases
  • FNAC proven Positive cervical nodes

Who the study is looking for

  • 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.

Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kolhapur Cancer Centre- Cancer Centers of America
Coordinator of this site? Confirm its status
KolhāpurIndiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.