Shoulder-sparing neck surgery: comparing levels I-III vs I-IV in oral cancer with no neck nodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares two selective neck dissection approaches in adults with clinically node-negative oral cavity cancer undergoing curative surgery. Participants are assigned to remove lymph nodes from levels I-III or from levels I-IV to see which method provides similar regional control and survival with potentially less morbidity. Outcomes include regional recurrence-free survival, overall and disease-free survival, and postoperative complications such as shoulder function and quality of life. The study aims to determine if extending surgery to level IV offers any oncologic benefit or just increases morbidity. Eligible patients are adults with histologically confirmed oral cavity squamous cell carcinoma, clinical stage T1-T4, N0, M0, and adequate health status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Kolhapur Cancer Centre- Cancer Centers of America
  Kolhāpur, Maharashtra, India Recruiting

Study contacts

• Principal investigator: Maroti B Wadewale, MDS, FHNO — Kolhapur Cancer Centre
• Study coordinator: Maroti B Wadewale, MDS, FHNO
• Email: dr.marotiwadewale59@gmail.com
• Phone: +918483851334

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.