Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy of Lower Rectal Cancer With Suspected Local Lymph Node Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
Treatment for Low rectal cancer, especially in patients with regional lymph node metastasis are quite different between Japanese guideline (JSCCR) and western countries' guideline (NCCN, ESMO). While Japanese scholars advocate total mesorectal excision (TME) plus lateral lymph node dissection (LLND), European and American scholars advocate TME alone after Neoadjuvant Chemo-radiotherapy (nCRT), without the need of LLND. Accordingly, this clinical trial is designed to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. It will provide high-level clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis
详细描述
There are significant differences between Japanese guidelines (JSCCR) and Western guidelines (NCCN, ESMO) in the treatment of low rectal cancer, especially in patients with regional lymph node metastasis. Japanese scholars advocated total meso rectal resection (TME) + Lateral lymph node dissection (LLND), However, European and American scholars advocate that only TME is used after new adjuvant chemo-radiation (nCRT), without LLND. Therefore, the purpose of this clinical trial was to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. This will provide a high level of clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage Ⅲ
- •Tumor is capable of performing radical recession
- •No past history of chemotherapy, pelvic radiation of other cancers.
- •Written informed consent
- •Lower tumor margin is confirmed below the peritoneal reflection
- •Clinical state T(1-3)N(1-2)M0 is confirmed by the multiple disciplines team(MDT) including surgeons,diagnostic radiologist,radiation oncologist and medical oncologists base on MRI and endorectal ultrasound -
排除标准
- •Past history of other cancers
- •Multiple Primary Colorectal Cancers or Familial adenomatous polyposis(FAP)
- •Combine with inflammatory bowl disease(IBD)
- •Recurrence tumor or invade other organs
- •Combine with obstruction,perforation or bleeding which need emergency surgery.
- •Local tumor invade the external sphincter, levator ani muscle or adjacent organs
- •Participant join other clinical trials in 4 weeks.
- •American Society of Anesthesiologists(ASA) ≥Ⅳ and/or Eastern Cooperative Oncology Group(ECOG) ≤2
- •Pregnant or lactating patients
- •Severity infection before operation
- •Psychological disorder
- •Severe dysfunction of organs or other contraindications
- •Cardiac infarction within six months
- •Severe pulmonary emphysema and pulmonary fibrosis
- •Doctor's decision for exclusion
- •Operative findings:
- •Tumor invade other organs Lower tumor margin is above the peritoneal reflection
结局指标
主要结局
3-year disease-free survival
时间窗: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
36 months after surgery
次要结局
- incidence of Postoperative complications(3 months)
- 5-year disease-free survival(From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Incidence of defecation dysfunction(3 years)
- overall survival(From the date of operation until the date of death,assessed up to 5 years)
- Operative time(Operation day)
- Blood loss(Operation day)
- Incidence of sexual dysfunction(3 years)
- Incidence of urinary dysfunction(3 years)
- 3-year local recurrence rate(From date of operation until the date of local-recurrence (up to 3 years))
- the score of quality of life(3 months after operation)