NCT05984485招募中3 期
TME vs TME+nCT in Low-risk LARC
Sun Yat-sen University6 个研究点 分布在 1 个国家目标入组 766 人开始时间: 2022年7月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 766
- 试验地点
- 6
- 主要终点
- 3-year Disease Free Survival
研究概览
简要总结
Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME) surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced rectal cancer. Randomly enrolling eligible patients into either the control group receiving neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving primary TME surgery, and subsequently comparing the clinical outcomes of the two groups
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
- •Newly diagnosed patients, aged 18 to 75 years;
- •Pathologically confirmed rectal adenocarcinoma;
- •Distance of the lower margin of the rectal tumor lesion from the anal margin <15cm;
- •High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the anal sphincter; negative mesorectal fascia (MRF) status; negative extramural vascular invasion (EMVI); no cancer nodules;
- •Exclusion of patients with non-local recurrence or distant metastases;
- •Absence of synchronous colorectal multiple primary cancers;
- •Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions;
- •The study physician assessed no difficulty in sphincter preservation;
- •patients and their families will be willing to participate in this study and provide written informed consent.
排除标准
- •Patients with concurrent other malignancies or a history of malignant tumors in the past;
- •Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery;
- •Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection;
- •Patients with poor anal function or fecal incontinence before surgery;
- •Patients with a history of inflammatory bowel disease or familial adenomatous polyposis;
- •Patients recently diagnosed with other malignancies;
- •Patients with ASA grade ≥ IV and/or ECOG performance status score > 2;
- •Patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery;
- •Patients with a history of severe mental illness;
- •Pregnant or lactating women;
- •Patients with uncontrolled infections before surgery;
- •Patients with other clinical or laboratory conditions, as determined by the investigator, that render them unsuitable for participation in this trial.
结局指标
主要结局
3-year Disease Free Survival
时间窗: 3 years after surgery
Defined as the proportion of patients who did not experience any of the following events from the beginning of the randomized subgroup to the end of the third year, which included disease progression, local recurrence, distant metastasis, or second primary colorectal cancer, or death from any cause.
次要结局
- The status of circumferential margin(Immediately after the surgery)
- Time to Postoperative first feed(1 months after surgery)
- Postoperative pain(1 months after surgery)
- Number of participants with treatment-related adverse events(1 month after neoadjuvant chemotherapy)
- The status of distal resection margin(Immediately after the surgery)
- Postoperative anal function(3 years after the surgery)
- Quality of life score(3 years after the surgery)
- 3-year overall survival(3 years after the surgery)
- Distance from the inferior resection margin to the tumor(Immediately after the surgery)
- 5-year overall survival(5 years after the surgery)
- Postiveoperative stay(1 months after surgery)
- Time to Postoperative first gas(1 months after surgery)
- 5-year Disease Free Survival(5 years after the surgery)
研究者
Yanhong Deng
Professor
Sun Yat-sen University
研究点 (6)
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