Survival Benefit of Elective Neck Dissection for Patients With T1,2N0M0 Oral Squamous Cell Carcinoma-A Prospective Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 448
- 试验地点
- 4
- 主要终点
- Whether elective neck dissection (END) has equal or higher survival rate to the wait and watch policy
研究概览
简要总结
Controversy over surgical treatment of clinically negative neck in early stage oral squamous cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the subject of clinical debate. Currently the clinically negative patients are treated by one of the two main policies: one is elective neck dissection; the other is "watchful waiting". The objective of this multi-institutional prospective randomized controlled study is to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be randomized into two groups: elective neck dissection versus watch and wait. The survival rate and the recurrence rate between two groups will be compared. The result of the study will give surgeons evidence-based instructions for the management of clinically negative neck in patients with cancer of oral cavity.
详细描述
There are controversies on the benefits of elective neck dissection (END) for clinically negative neck in early stage oral squamous cell carcinoma. The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. We initiate this multi-institutional study, expecting 448 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: END and "watch and wait". The END group will undergo one stage surgery of END and primary tumor excision, and the "watch and wait"group will be treated with primary tumor excision transorally as initial treatment, with rigorous postoperation consultation. All patients will be followed up with at least 5 years after initial treatment, and the survival rate and the recurrence rate between groups will be compared.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:20 to 70 years old, both male and female
- •Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the oral tongue, buccal mucosa, gingiva, floor of mouth, and hard palate
- •The maximum diameter of the primary tumor is less than 4cm
- •Clinical nodal staging has been confirmed negative via both clinical examination and imaging (MRI or lateral and central neck ultrasound)
- •With at least 1-year's expected survival time
- •Willing to join the protocol and is able to give written informed consent
排除标准
- •Patient with severe cardiac insufficiency, hepatic insufficiency, renal insufficiency, of systemic infection diseases
- •The patient is pregnant or lactating
- •Patients with a history of surgical treatment, radiotherapy, chemotherapy, biotherapy and targeted therapy, et al, before participating in the study
- •Patient is currently participating in another investigational drug study
结局指标
主要结局
Whether elective neck dissection (END) has equal or higher survival rate to the wait and watch policy
时间窗: 5 years
The 5-year's survival and the disease free survival of the two group of patients are being measured and compared with one and other, so the survival benefit of the two policy is evaluated.
次要结局
- quality of life(5 years)
- Does END have the equal or lower recurrence rate to the wait and watch policy(5 years)
研究者
Gui-Qing Liao
Guanghua School of Stomatology, Hospital of Stomatology
Sun Yat-sen University