Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 14
- 主要终点
- pathologic complete response (pCR)
研究概览
简要总结
The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.
详细描述
PURPOSE
To demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathological complete response (pCR) and reflects on disease-free survival (DFS) and overall survival (OS) rather than standard timing. Eight weeks are the current standard interval to surgery after neoadjuvant treatment, while 12 weeks represent the "minimum" longer time interval to determine further tumor modifications and the "a priori" choice to avoid hypothetical surgical detrimental effect (postoperative complications related to radiation therapy).
Primary Endpoint
- pCR
Secondary Endpoints
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •cT3/4N0/+M0 confirmed on CT-scan, MRI (stratification for T3a-b-c-d) 3
- •Tumor starting from the distal or medium rectum (even those crossing the peritoneal reflection at distal margin, within 15 cm from the anal margin)
- •Histologically-proven adenocarcinoma of the rectum
- •Eligible for a resective surgery with TME (low anterior resection, intersphincteric resection, abdominoperineal resection)
- •Eligible for resection by minimally-invasive surgery (standard or robotic-assisted laparoscopic procedure, all robotic systems will be accepted)
- •Eligible for chemoradiation treatment
- •Able to give written informed consent
- •Capable of completing required questionnaires at time of consent (provided questionnaires are available in a language spoke fluently by the participant)
排除标准
- •Metastatic disease
- •Squamous carcinoma of the anal canal
- •Synchronous colorectal tumors requiring multi-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
- •History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
- •Pregnancy
- •Unable to complete neoadjuvant treatment
- •Unable to give free informed consent
- •Previous radiation treatment on the pelvis
- •Inflammatory bowel disease
- •Hereditary colorectal disease
- •Previous tumors other than non-melanoma skin cancer, papillary or follicular thyroid cancer
- •Participation in another rectal cancer clinical trial relating to the topic of this trial
研究组 & 干预措施
Standard Interval Time Arm
Minimally invasive surgery after 8 weeks from chemoradiation treatment
干预措施: Surgery after 8 weeks from chemoradiation treatment (Procedure)
Delayed Interval Time Arm
Minimally invasive surgery after 12 weeks from chemoradiation treatment
干预措施: Surgery after 12 weeks from chemoradiation treatment (Procedure)
结局指标
主要结局
pathologic complete response (pCR)
时间窗: 8-12 weeks
Pathologic Complete response on cancer defined as absence of cancer cells on specimen
次要结局
- DFS(5 years)
- OS(5 years)
研究者
Igor Monsellato
Principal Investigator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria