Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Regional Recurrence-Free Survival (RRFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Selective Neck Dissection (Levels I-IV) (Procedure)
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.
干预措施: Modified Neck Dissection (Levels I-V) (Procedure)
结局指标
主要结局
Regional Recurrence-Free Survival (RRFS)
时间窗: 3 years after surgery
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.
次要结局
- 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)
- Postoperative Surgical Morbidity(Within 30 days after surgery)
- Shoulder function assesment with Shoulder pain and disability index(Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery)
研究者
Maroti Wadewale
Consultant, Head and neck surgical oncology
Kolhapur Cancer Centre - Cancer Centers of America