Timing for Rectal Surgery After ChST
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Complete pathologic response assessed by pathologist Dworak scale
研究概览
简要总结
The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 8 weeks.
Hypothesis: Greater down-staging and tumor regression is observed when surgery is delayed to 12 weeks after completion of chemoradiotherapy compared to 8 weeks.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Eastern Cooperative Oncology Group (ECOG) 0-1,
- •American Society of Anesthesiologists' (ASA) score I-III
- •Histological confirmation of adenocarcinoma of rectum
- •T3 or T4 N0, T any N positive cancer on MRI, without metastasis on CT scan
- •Undergoing preoperative radiotherapy/ chemotherapy
- •Curative total mesorectal excision intended
- •Written informed consent
- •Patients undergoing preoperative radiotherapy should not be excluded
排除标准
- •Patients with distant metastasis
- •T1 or T2, N0 cancer on MRI
- •Rectal cancer 12 cm above the dentate line
- •Contraindications to MRI
- •Patients previously treated of pelvic organ cancer
- •Medical or psychiatric conditions that compromise the patients ability to give informed consent
结局指标
主要结局
Complete pathologic response assessed by pathologist Dworak scale
时间窗: 6 months
Dworak scale assesses the response: 0. No regression; 1. Predominantly tumor with significant fibrosis and/or vasculopathy; 2. Predominantly fibrosis with scattered tumor cells (slightly recognizable histologically); 3. Only scattered tumor cells in the space of fibrosis with/without acellular mucin; 4. No vital tumor cells detectable
次要结局
- Pathological response assessed by pathologist using Dworak scale(6 months)
- Total mesorectal excision (TME) quality assessed by TME completeness scale (by P.Quircke)(8-12 weeks)
- Local recurrence assessed by CT scan/MRI/endoscopy(5 years)
- Clinical response assessed using MRi(8 weeks (2 months))
- Incidence of Mortality assessed by Clavien-Dindo scale(30 days)
- Distant recurrence assessed by CT scan(5 years)
- Radiotherapy skin toxicity assessed by EORTC scale(5 years)
- Radiotherapy toxicity assessed by EORTC scale(5 years)
- Oncological outcome - overall survival(5 years)
- Quality of Life assessed by Low anterior resection syndrome score(1 year)
- Urinary catheter removal timing(3 months)
- Incidence of Treatment-Emergent Adverse Events as assessed by Clavien-Dindo scale(30 days)
- Oncological outcome - disease-free survival(5 years)
- Immune response assessed(1 year)
研究者
Audrius Dulskas
Assoc. profesor
National Cancer Institute, Lithuania