Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread (ExtentN1)
Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial
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.
연구 개요
상태
정황
상세 설명
Cervical lymph node metastasis is the most important prognostic factor in oral cavity squamous cell carcinoma (OCSCC). Surgical management of the neck is an integral component of treatment; however, the optimal extent of neck dissection for patients with clinically node-positive (cN1) disease remains uncertain. Although modified neck dissection (levels I-V with preservation of non-lymphatic structures) has traditionally been recommended for node-positive disease, several retrospective studies have suggested that carefully selected patients with limited nodal disease may achieve comparable regional control with a less extensive selective neck dissection. Nevertheless, these studies are subject to selection bias, and no adequately powered randomized controlled trial has directly compared these surgical approaches.
Dissection of lower cervical nodal levels may increase operative time and postoperative morbidity, including shoulder dysfunction, sensory deficits, chyle leak, and impairment in quality of life. Reducing the extent of neck dissection without compromising oncologic outcomes could improve postoperative functional recovery and patient-reported outcomes while maintaining regional disease control.
The ExteNT N1 Trial is designed to address this evidence gap by comparing selective neck dissection (levels I-IV) with modified neck dissection (levels I-V) in patients with resectable cN1 OCSCC. In addition to evaluating oncologic outcomes, the study incorporates validated functional and quality-of-life assessments to comprehensively evaluate the impact of the two surgical strategies. Participants will receive standard treatment for the primary tumor, and adjuvant therapy will be administered according to final histopathological findings and contemporary treatment guidelines.
The findings of this trial are expected to provide high-level evidence to guide the surgical management of the clinically N1 neck in OCSCC. If selective neck dissection demonstrates equivalent oncologic outcomes with lower morbidity, it may support a change in surgical practice by reducing unnecessary treatment while preserving function and quality of life.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Maroti B Wadewale, MDS, FHNO
- 전화번호: +918483851334
- 이메일: dr.marotiwadewale59@gmail.com
연구 연락처 백업
- 이름: Parag J Watve, MS, FHNS
- 전화번호: +919823109918
- 이메일: paragwatve@kolhapurcancercentre.com
연구 장소
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Maharashtra
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Kolhāpur, Maharashtra, 인도, 416004
- 모병
- Kolhapur Cancer Centre
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연락하다:
- Maroti B Wadewale, MDS, FHNO
- 전화번호: +918483851334
- 이메일: dr.marotiwadewale59@gmail.com
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연락하다:
- Yogesh Anap, MD
- 전화번호: +919867155930
- 이메일: yogesh.anap1@gmail.com
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수석 연구원:
- Maroti B Wadewale, MDS, FHNO
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부수사관:
- Parag Watve, MS, FHNS
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Arm 1- Selective neck dissection level I to level IV
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.
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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.
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활성 비교기: Arm 2- Modified Neck Dissection (Levels I-V)
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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Regional Recurrence-Free Survival (RRFS)
기간: 3 years after surgery
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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.
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3 years after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Survival (OS)
기간: Up to 3 years after surgery
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Overall survival is defined as the time from definitive surgery until death from any cause.
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Up to 3 years after surgery
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Disease-Free Survival (DFS)
기간: Up to 3 years after surgery
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Disease-free survival is defined as the time from definitive surgery to the first documented local, regional, or distant recurrence, or death from any cause.
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Up to 3 years after surgery
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Level-wise Cervical Lymph Node Metastasis
기간: At the time of surgery (histopathological examination)
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Distribution of histopathologically confirmed metastatic lymph nodes according to cervical nodal level.
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At the time of surgery (histopathological examination)
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Nodal Yield
기간: At the time of surgery
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Total number of lymph nodes retrieved during neck dissection and confirmed by histopathological examination.
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At the time of surgery
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Shoulder Function assesment
기간: Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year
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Shoulder function will be assessed using the Constant-Murley Score (0-100 points), with higher scores indicating better shoulder function.
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Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year
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Postoperative Surgical Morbidity
기간: Within 30 days after surgery
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Incidence of postoperative complications, including chyle leak, hematoma, wound infection, seroma, cranial nerve injury
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Within 30 days after surgery
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Shoulder function assesment with Shoulder pain and disability index
기간: Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery
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Shoulder pain and disability will be assessed using theShoulder pain and disability index questionnaire.
Scores range from 0 to 100, with higher scores indicating greater pain and disability.
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Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ExteNTN1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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