NCT01037049Unknown2 期
Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 237
- 试验地点
- 45
- 主要终点
- The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].
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 6 weeks.
Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Aged > 18
- •Informed written consent
- •Histological confirmation of adenocarcinoma of rectum
- •Undergoing pre-operative radiotherapy/ chemotherapy
- •Completion of pre-operative treatment
排除标准
- •Aged < 18
- •Absence of pre-operative RT/CT
- •Medical/ psychiatric conditions that compromise the patients ability to give informed consent
- •Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker
研究组 & 干预措施
Group 1
No Intervention
Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
Group 2
Experimental
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
干预措施: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy (Other)
结局指标
主要结局
The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].
时间窗: 6-12 weeks
次要结局
- Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI].(3 months)
- Difference in proportion of patients in each arm undergoing sphincter saving surgery.(3 months)
- Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity.(3 months)
- An analysis will also be undertaken using multivariate and linear regression analysis to evaluate the association of ypT and ypN stage as a potential independent predictors of SUV (max) baseline and after radiotherapy (pre-surgery) in the two arms.(3 months)
- Local and distant recurrence rates.(5 years)
- Radiotherapy related toxicity rates.(5 years)
研究者
研究点 (45)
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