Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread
ExtentN0
ExteNT N0 Trial- Extent of Neck Treatment in Clinically N0 Oral Cancer: A Randomized Controlled Trial
1 other identifier
interventional
267
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2026
CompletedFirst Submitted
Initial submission to the registry
July 9, 2026
CompletedFirst Posted
Study publicly available on registry
July 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
July 24, 2026
July 1, 2026
4.4 years
July 9, 2026
July 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Regional recurrence free survival (RRFS)
Regional recurrence-free survival is defined as the time from the date of surgery to the first documented regional recurrence in the cervical lymph nodes or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last disease assessment.
From the date of surgery to 3 years after surgery
Secondary Outcomes (7)
Overall Survival (OS)
From the date of surgery to 3 years after surgery.
Disease-Free Survival (DFS)
From the date of surgery to 3 years after surgery.
Occult Nodal Metastasis Rate
Within 4 weeks after surgery (following final histopathological examination).
Patterns of Regional Nodal Failure
From the date of surgery to 3 years after surgery.
Shoulder Function
Baseline (preoperatively) and at 1 month, 3 months, 6 months, 12 months, and 24 months after surgery.
- +2 more secondary outcomes
Study Arms (2)
Arm 1- Selective neck dissection involving cervical lymph node levels I, II, and III.
ACTIVE COMPARATORThe patients belongs to this group will undergo selective neck dissection level I to II, which will include: removal of lymph node Levels Ia, Ib, IIa and III. The contralateral neck will be addressed when the lesion reaches or crosses the midline, with the extent of dissection determined by the assigned study arm. Any intraoperatively obvious/suspicious lymph nodes will be sent for frozen section, and if positive, a modified neck dissection will be performed.
Arm 2- Selective neck dissection level I, II, III and IV
EXPERIMENTALThe patients belongs to this group will undergo selective neck dissection level I to II, which will include: removal of lymph node Levels Ia, Ib, IIa, III and IV. The contralateral neck will be addressed when the lesion reaches or crosses the midline, with the extent of dissection determined by the assigned study arm. Any intraoperatively obvious/suspicious lymph nodes will be sent for frozen section, and if positive, a modified neck dissection will be performed.
Interventions
Selective neck dissection (Levels I-III) involves surgical removal of ipsilateral cervical lymphatic tissue from neck levels I, II, and III during primary resection of oral squamous cell carcinoma in patients with a clinically node-negative (cN0) neck. The procedure is performed according to standard oncological principles with preservation of the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle unless their sacrifice is required because of direct tumor involvement.
Selective Neck Dissection (Levels I-IV)- Selective neck dissection (Levels I-IV) involves surgical removal of ipsilateral cervical lymphatic tissue from neck levels I, II, III, and IV during primary resection of oral squamous cell carcinoma in patients with a clinically node-negative (cN0) neck. The procedure is performed according to standard oncological principles with preservation of the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle unless their sacrifice is required because of direct tumor involvement.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kolhapur Cancer Centre- Cancer Centers of America
Kolhāpur, Maharashtra, 416234, India
Related Publications (7)
Shah JP, Gil Z. Current concepts in management of oral cancer--surgery. Oral Oncol. 2009 Apr-May;45(4-5):394-401. doi: 10.1016/j.oraloncology.2008.05.017. Epub 2008 Jul 31.
PMID: 18674952RESULTTaylor RJ, Chepeha JC, Teknos TN, Bradford CR, Sharma PK, Terrell JE, Hogikyan ND, Wolf GT, Chepeha DB. Development and validation of the neck dissection impairment index: a quality of life measure. Arch Otolaryngol Head Neck Surg. 2002 Jan;128(1):44-9. doi: 10.1001/archotol.128.1.44.
PMID: 11784253RESULTCappiello J, Piazza C, Giudice M, De Maria G, Nicolai P. Shoulder disability after different selective neck dissections (levels II-IV versus levels II-V): a comparative study. Laryngoscope. 2005 Feb;115(2):259-63. doi: 10.1097/01.mlg.0000154729.31281.da.
PMID: 15689746RESULTResults of a prospective trial on elective modified radical classical versus supraomohyoid neck dissection in the management of oral squamous carcinoma. Brazilian Head and Neck Cancer Study Group. Am J Surg. 1998 Nov;176(5):422-7. doi: 10.1016/s0002-9610(98)00230-x.
PMID: 9874426RESULTPantvaidya GH, Pal P, Vaidya AD, Pai PS, D'Cruz AK. Prospective study of 583 neck dissections in oral cancers: implications for clinical practice. Head Neck. 2014 Oct;36(10):1503-7. doi: 10.1002/hed.23494. Epub 2014 Jan 13.
PMID: 23996343RESULTD'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
PMID: 26027881RESULTWoolgar JA. Histopathological prognosticators in oral and oropharyngeal squamous cell carcinoma. Oral Oncol. 2006 Mar;42(3):229-39. doi: 10.1016/j.oraloncology.2005.05.008. Epub 2005 Sep 16.
PMID: 16150633RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maroti B Wadewale, MDS, FHNO
Kolhapur Cancer Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
July 9, 2026
First Posted
July 24, 2026
Study Start
April 22, 2026
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
September 1, 2030
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
No individual participant data (IPD) will be shared with other researchers. The study investigators do not have a plan to make de-identified participant-level data publicly available.