Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible … (NCT07726199) | Clinical Trial Compass
RecruitingNot Applicable
Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread
India267 participantsStarted 2026-04-22
Plain-language summary
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.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing different ways of treating the neck in oral cancer patients who don't have visible spread to their lymph nodes — can you walk me through what those different approaches actually are, and what the main tradeoff between them is?
2Since the trial is measuring 'regional recurrence free survival,' meaning whether the cancer comes back in the neck area, how does my specific tumor size, location, and pathology affect my personal risk of hidden neck spread, and does that change which approach might make more sense for me?
3This trial is listed as Phase NA, which suggests it may be a surgical or procedural comparison rather than a drug trial — does that mean the safety profile of the options being compared is already reasonably well understood, or are there still unknowns I should factor in?
4If I don't join this trial, what would the standard recommended treatment for my neck be right now, and how confident is the evidence behind that recommendation compared to what this study is trying to find out?
5What would participation in this trial actually require of me in terms of follow-up visits, imaging, or procedures over time, and how might that fit with my work and family situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Regional recurrence free survival (RRFS)
Timeframe: From the date of surgery to 3 years after surgery
Trial details
NCT IDNCT07726199
SponsorKolhapur Cancer Centre - Cancer Centers of America