Development of an IDEAL Framework to Standardise the Complex Intervention of Cytoreductive Surgery for Colorectal Peritoneal Metastases: a Necessary Step to Phase III Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Peritoneal Cancer Index (PCI) Score
研究概览
简要总结
Cytoreduction surgery (CRS) followed by hyperthermic intra-operative peritoneal chemotherapy (HIPEC) is a relatively new treatment for selected patients with peritoneal metastases of colorectal origin (PMCR). Data from outside of trials suggest that CRS and HIPEC improves survival compared with the current standard care (chemotherapy).
The big challenge is to do trials in this setting - as the intervention is complex, and there are wide variations in the process and recording of outcomes. If trials can confirm the findings from non-randomised studies there are an estimated 1000 to 2000 patients who may benefit from this intervention in the UK each year. The aim of this study is to develop a framework which can be used to undertake a randomised trial in patients with PMCR suitable for CRS with or without HIPEC.
The investigators will address this using the principles of the IDEAL (Idea, Development, Evaluation, Assessment & Long term study) framework. Here, a pre-trial feasibility study will be performed between the two national peritoneal tumour treatment centres (Manchester and Basingstoke).
This study is designed as such that it will take place over the following four stages:
Stage 1. Comparing the treatment data from 100 operations from each of the two centres to identify which of the key components of the intervention differ as well as testing for differences in overall survival and recurrence free survival.
Stage 2. Identifying sources of these differences by selecting up to 25 patients and investigating the variation in the way surgeons score key aspects of the procedure
Stage 3. Development of a 'trial manual' with standardised definitions (to minimise any differences)
Stage 4. Test how well people follow the manual in practice. After this study is complete, it will be possible to use the resulting trial manual to design future randomised trials to test the most suitable clinical question.
详细描述
The 2010 National Institute Centre for Excellence (NICE) IGP331 guidance recognised that there is sufficient evidence (mainly from non-randomised comparative studies) that cytoreduction surgery (CRS) followed by hyperthermic intraoperative peritoneal chemotherapy (HIPEC), in selected patients with peritoneal metastases of colorectal origin (PMCR), improves survival compared with systemic chemotherapy, current standard care. The guidance recognised that this intervention is associated with considerable morbidity and mortality, and accordingly, should be delivered with special arrangements for clinical governance, consent and research, and include trials.
In the UK, with 37,000 new colorectal cancers per annum, there are an estimated 1000 to 2000 patients who may benefit from this intervention. There are currently two treatment centres (Manchester and Basingstoke), with additional new centres in Birmingham and Dublin starting to roll out to meet this unmet need.
There is only one published randomised trial in this field, which is now mainly historic (2003). There are a small number of on-going trials, but these are small-scale and have encountered various early problems, which can be summarised as follows:
(i) Wide variation in the treatment process, such that there has been between-arm imbalances in key prognostic components (such as different case mix between arms); and
(ii) Wide variation of the reported treatment-related outcomes, such that it is unclear whether results are generalizable to other centres.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18
- •Diagnosed with histologically proven peritoneal metastasis of colorectal origin
- •Undergone Cytoreductive Surgery with HIPEC at either The Christie NHS Foundation Trust or Hampshire Hospitals NHS Foundation Trust.
- •Able to give informed consent
- •Treatment with curative intent
- •No diagnosed distant metastasis
排除标准
- •Under the age of 18
- •Palliative patients
- •Diagnosed distant metastasis
结局指标
主要结局
Peritoneal Cancer Index (PCI) Score
时间窗: At time of procedure
This scale measures the extent of peritoneal cancer throughout the peritoneal cavity. The range of this scale is from 0 to 39. 0 = no disease within the peritoneal cavity 0-9 = minimal disease 10-29 = moderate disease 30-39 = extensive disease Lower values are considered a better outcome for the patient.
次要结局
- Completeness of Cytoreduction (CC) Score(At time of procedure)
- Recurrence Free Survival(3 years after procedure)
- Overall Survival(3 years after procedure)
研究者
Lee Malcomson
Research Associate
University of Manchester