Clinical trial · Observational
Development of an IDEAL Framework to Standardise Cytoreductive Surgery for Colorectal Peritoneal Metastases
Development of an IDEAL Framework to Standardise the Complex Intervention of Cytoreductive Surgery for Colorectal Peritoneal Metastases: a Necessary Step to Phase III Trials
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Peritoneal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytoreduction and Heated Intraperitoneal Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- The Christie NHS FT
- description
- Patients treated by Cytoreduction and Heated Intraperitoneal Surgery at The Christie NHS Foundation Trust (one of the two initial, primary treatment centres) for Colorectal Peritoneal Metastasis.
- interventionNames
- Procedure: Cytoreduction and Heated Intraperitoneal Surgery
- label
- Hampshire Hospitals NHS FT
- description
- Patients treated by Cytoreduction and Heated Intraperitoneal Surgery at Hampshire Hospitals NHS Foundation Trust (one of the two initial, primary treatment centres) for Colorectal Peritoneal Metastasis.
- interventionNames
- Procedure: Cytoreduction and Heated Intraperitoneal Surgery
Primary outcomes (1)
- measure
- Peritoneal Cancer Index (PCI) Score
- timeFrame
- At time of procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Under the age of 18 * Palliative patients * Diagnosed distant metastasis
References
Publications (4)
- BACKGROUNDNICE. Cytoreduction surgery followed by hyperthermic intraoperative peritoneal chemotherapy for peritoneal carcinomatosis. IPG331. 2010.
- RESULTMcCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8. PMID 19782876
- RESULTVerwaal VJ, van Ruth S, de Bree E, van Sloothen GW, van Tinteren H, Boot H, Zoetmulder FA. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol. 2003 Oct 15;21(20):3737-43. doi: 10.1200/JCO.2003.04.187. PMID 14551293
- RESULTBlazeby JM, Blencowe NS, Titcomb DR, Metcalfe C, Hollowood AD, Barham CP. Demonstration of the IDEAL recommendations for evaluating and reporting surgical innovation in minimally invasive oesophagectomy. Br J Surg. 2011 Apr;98(4):544-51. doi: 10.1002/bjs.7387. Epub 2011 Jan 18. PMID 21246515