Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 508
- 试验地点
- 4
- 主要终点
- Overall survival
研究概览
简要总结
The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers.
The main questions it aims to answer are:
- Survival outcomes
- Morbidity outcomes
- Cost-effectiveness
Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.
详细描述
Based on the current literature, we know that elective neck dissection (END) is mandatory in clinically node-negative early oral cancers. However, this leads to overtreatment and morbidity in about 55-80% of patients. The emergence of recent level I evidence makes SNB the standard of care in this setting. However, its limitation of being a two-staged procedure, steep learning curve, the burden on resources, lack of infrastructure, short-lasting decrease in morbidity and lack of cost-effectiveness data limits its wide applicability. It is our routine departmental practice of performing limited neck dissection clearing level I-III/IV sparing level IIb which is cleared only if level IIa is metastatic. It is hypothesized that limited END would limit the morbidity of shoulder dysfunction and be a more feasible and cost-effective treatment option which could be a suitable alternative to SNB in this setting without compromising the survival outcomes. With this background, we propose to embark upon a phase III RCT comparing the oncologic outcomes and morbidity of SNB versus limited END. We hypothesize that limited END would have survival outcomes non-inferior, morbidity similar to SNB with higher cost-effectiveness.
Aims and objectives:
Aim To compare the survival outcomes, morbidity and cost-effectiveness of SNB versus limited END in node-negative early oral cancers
Primary objective
- Overall survival
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years of age
- •Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa
- •T1 and T2 lesions as per AJCC TNM 8 edition
- •Clinicoradiologically node negative
- •Amenable to per oral excision
- •Treatment naïve
- •No other site of malignancy
排除标准
- •Previous surgery in the head and neck region,
- •Upper alveolar or palatal lesions
- •Large heterogeneous leukoplakia or other premalignant lesions
- •Previous malignancy in the head and neck region
- •Patients requiring the free flap reconstruction
结局指标
主要结局
Overall survival
时间窗: 3 years
Defined from the date of randomization to death due to any cause
次要结局
- Disease free survival(3 years)
- Shoulder morbidity(Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment)
- Health related Quality of life(Longitudinally at preoperatively, 3 months, at 6 months, 12 months and 24 months of treatment)
- Neck nodal recurrence(3 years)
- Adverse events related to the surgical procedure and lymphedema(The lymphedema rating will be done at 3 months, at 6 months, 12 months and 24 months of treatment)
- Cost effectiveness(3 years)
研究者
Richa Vaish
Professor and Surgeon
Tata Memorial Hospital