NCT05563922招募中2 期
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Early Low Rectal Carcinoma: A Prospective, Exploratory Trial
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Organ preservation rate at 3 years
研究概览
简要总结
This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery （TEM） or endoscopic local resection for early low rectal cancer（cT 1-3N0M0）.Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life （QoL） will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age≥18 years
- •cT1-3N0M0 assessed by CT, MRI and ultrasound colonoscopy
- •Rectal adenocarcinoma confirmed by biopsy pathology and the lower edge of the lesion was within 5cm from the anal edge
- •Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment, meanwhile is suitable for the implementation of organ preservation strategy after discussion within the multidisciplinary team of the hospital
- •No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
- •No contraindications to chemoradiotherapy
- •No other colorectal organic diseases
- •Voluntarily sign the informed consent
排除标准
- •Have received previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
- •Patients with concurrent colorectal organic diseases
- •Patients with familial polyposis
- •Patients with a previous history of colorectal surgery or pelvic radiotherapy that may affect the outcome of this treatment
- •Pregnant or lactating women
- •The patient or family members could not understand the conditions and objectives of this study
- •With a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, their clinical severity may hinder the signing of an informed consent form or affect their compliance with oral medication
- •It is difficult to achieve complete remission base on existing evidence , such as: maximum diameter of cT2/T3 tumor>4cm; suspicious Lateral lymph nodes (maximum diameter) =5mm; baseline CEA≥100; biopsy pathology contains signet ring cell carcinoma mucinous adenocarcinoma; evaluation team determines whether circumferential constrictive tumor should be included or not when necessary Severe heart disease, such as symptomatic coronary heart disease, New York Cardiology Association (NYHA) grade II or above severe congestive heart failure, or severe arrhythmia requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months
- •Organ transplantation requires immunosuppressive therapy
- •Serious uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- •The baseline blood routine and biochemical indexes of the subject do not meet the following criteria: hemoglobin ≥90g / L; absolute neutrophil count (ANC) ≥1.5*10^9 / L; platelet ≥100*10^9 / L; ALT and AST≤ 2.5 times normal upper limit; ALP ≤2.5 times normal upper limit; serum total bilirubin <1.5 times normal upper limit; serum normal creatinine"<1 time upper limit; and serum albumin ≥30g / L
结局指标
主要结局
Organ preservation rate at 3 years
时间窗: 3 years
Patients with a good pathological response（ypT 0-1 without neural vascular invasion）after neoadjuvant treatment followed by transanal endoscopic microsurgery（TEM）or endoscopic local resection will be offered an organ preservation strategy
次要结局
- 3-year distant metastases rate(3 years)
- 3-year local recurrence rate(3 years)
- 3-year overall survival（OS） rates(3 years)
- Quality of life (EORTC-QLQ-C 30, psychological status)(20 weeks)
- Clinical complete response rate after neoadjuvant chemoradiotherapy(18 weeks)
- 5-year Disease-free survival（DFS）rates(5 years)
- 5-year overall survival（OS） rates(5 years)
- 3-year Disease-free survival（DFS）rates(3 years)
研究者
研究点 (1)
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