A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.
详细描述
Oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases. Lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy. Recently, cervical lymph node dissection(CLND) is performed in the presence of oral squamous cell carcinoma. However, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial. CLND will represent over-treatment in some case of early-stage oral squamous cell carcinoma. Therefore, How to accurately predict whether a patient should be performed CLND is important. Our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma. The purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.
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
- Double (Investigator, Outcomes Assessor)
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
- •Oral squamous cell carcinoma is confirmed by pathology;
- •The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;
- •The primary lesion is no more than 4cm;
- •Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;
- •Patients and families agree to participate in the study;
- •Patients do not have cognitive disorders.
排除标准
- •Do not meet the inclusion criteria;
- •The primary lesion is more than 4cm or invade adjacent tissues;
- •Do not review on schedule;
- •Patients receive not only surgical procedures, but other antineoplastic treatment;
- •There are serious adverse events after operation;
- •Patients quit the study voluntarily;
- •Patients quit the study because of physical condition.
研究组 & 干预措施
Low-level tumor budding group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
干预措施: Resection for primary lesion only (Procedure)
High-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
干预措施: Resection for primary lesion and cervical lymph node dissection (Procedure)
High-level tumor budding group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
干预措施: Resection for primary lesion only (Procedure)
Low-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
干预措施: Resection for primary lesion and cervical lymph node dissection (Procedure)
结局指标
主要结局
Disease free survival
时间窗: After the first year, review every three months at a time；The next four years, review every six months at a time.
The time from the start of surgery to the discovery of the first cervical lymphatic metastases
Five-year survival rate
时间窗: After the first year, review every three months at a time；The next four years, review every six months at a time.
The time from the first operation to death was recorded
次要结局
- Recurrence rate(After the first year, review every three months at a time；The next four years, review every six months at a time.)
- Evaluation of quality of life(After the first year, review every three months at a time；The next four years, review every six months at a time.)
研究者
Jinsong Hou
Vice Director
Sun Yat-sen University