Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread

NCT07717307 | Not Yet Recruiting DMC

• 1 other identifier: ExteNTN1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Cavity Squamous Cell Carcinoma

Keywords

Oral Cavity Squamous Cell Carcinoma; Oral Cancer; Head and Neck Cancer; Neck Dissection; Modified Neck Dissection; Cervical Lymph Node Metastasis

Outcome Measures

Primary Outcomes (1)

• Regional Recurrence-Free Survival (RRFS)

  Regional recurrence-free survival is defined as the time from the date of definitive surgery to the first documented regional recurrence in the cervical lymph nodes or death from any cause, whichever occurs first. Regional recurrence will be confirmed by clinical examination, imaging, and histopathological evaluation whenever feasible.

  3 years after surgery

Secondary Outcomes (7)

• Overall Survival (OS)

  Up to 3 years after surgery

• Disease-Free Survival (DFS)

  Up to 3 years after surgery

• Level-wise Cervical Lymph Node Metastasis

  At the time of surgery (histopathological examination)

• Nodal Yield

  At the time of surgery

• Shoulder Function assesment

  Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year

Study Arms (2)

Arm 1- Selective neck dissection level I to level IV

EXPERIMENTAL

Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral selective neck dissection involving cervical lymph node levels I-IV. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.

Procedure: Selective Neck Dissection (Levels I-IV)

Arm 2- Modified Neck Dissection (Levels I-V)

ACTIVE COMPARATOR

Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral modified neck dissection involving cervical lymph node levels I-V while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.

Procedure: Modified Neck Dissection (Levels I-V)

Interventions

Modified Neck Dissection (Levels I-V) PROCEDURE

Modified neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, IV, and V on the ipsilateral side while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.

Arm 2- Modified Neck Dissection (Levels I-V)

Selective Neck Dissection (Levels I-IV) PROCEDURE

Selective neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, and IV on the ipsilateral side while preserving uninvolved non-lymphatic structures. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.

Arm 1- Selective neck dissection level I to level IV

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven squamous cell carcinoma of oral cavity will be included
• Clinical stage T1-T4, N1, M0
• cN1 neck on clinical examination and imaging (CT/MRI)
• Single node which is FNAC proven without any other significant nodes.
• Patients with ASA grade II and I.
• Understands the protocol and able to give informed consent.

You may not qualify if:

• Recurrent cases
• Multiple significant nodes
• Nodes clinical/radiological with ENE
• Single metastatic node at level III/IV/V
• Single metastatic node with other suspicious nodes
• Patients with a history of head and neck radiation therapy treatment
• Previous history of any malignancy

Sponsors & Collaborators

• Kolhapur Cancer Centre - Cancer Centers of America: lead

Study Sites (1)

Kolhapur Cancer Centre

Kolhāpur, Maharashtra, 416004, India

Location

Related Publications (4)

• Pantvaidya 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: 23996343 RESULT

• Liang L, Zhang T, Kong Q, Liang J, Liao G. A meta-analysis on selective versus comprehensive neck dissection in oral squamous cell carcinoma patients with clinically node-positive neck. Oral Oncol. 2015 Dec;51(12):1076-81. doi: 10.1016/j.oraloncology.2015.10.005. Epub 2015 Oct 23.

  PMID: 26500065 RESULT

• Hashmi SS, Abbas A, Bukhari A, Saeed J, Shafqat A, Siddique AH, Buksh AR, Murtaza G. Selective Neck Dissection for Node-Positive Oral Cavity Squamous Cell Carcinoma: A Retrospective Cohort Study. Int Arch Otorhinolaryngol. 2022 Feb 22;26(4):e630-e635. doi: 10.1055/s-0041-1741437. eCollection 2022 Oct.

  PMID: 36405475 RESULT

• Shin YS, Koh YW, Kim SH, Choi EC. Selective neck dissection for clinically node-positive oral cavity squamous cell carcinoma. Yonsei Med J. 2013 Jan 1;54(1):139-44. doi: 10.3349/ymj.2013.54.1.139.

  PMID: 23225810 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Maroti B Wadewale, MDS, FHNO

CONTACT

+918483851334; dr.marotiwadewale59@gmail.com

Parag J Watve, MS, FHNS

CONTACT

+919823109918; paragwatve@kolhapurcancercentre.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the surgical interventions, neither the participants nor the operating surgeons can be blinded to treatment allocation. However, postoperative functional assessments (e.g., shoulder function) and quality-of-life evaluations will be performed, whenever feasible, by trained assessors who are unaware of the assigned treatment arm. Data analysts will also be blinded to treatment allocation until the primary analysis is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Head and neck surgical oncology

Model Details: Participants will be randomized in a 1:1 ratio to one of two surgical treatment arms using a computer-generated stratified permuted block randomization sequence with variable block sizes. Stratification will be based on primary tumor subsite and clinical T stage to ensure balanced allocation. This is an open-label trial because blinding of surgeons and participants is not feasible due to the nature of the surgical interventions. However, postoperative functional and quality-of-life assessments will be performed by outcome assessors who are blinded to treatment allocation whenever feasible. All analyses will follow the intention-to-treat principle.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 22, 2031
• Study Completion (Estimated): April 23, 2031
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)