Development of an IDEAL Framework to Standardise Cytoreductive Surgery for Colorectal Peritoneal Metastases

NCT03733184 | Completed DMC

• 2 other identifiers: 19944231407
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Colorectal Cancer Metastatic; Peritoneal Metastases

Keywords

Colorectal; Cancer; Peritoneal Metastasis; IDEAL; PCI; CRPM; Colorectal Peritoneal Metastasis

Outcome Measures

Primary Outcomes (1)

• Peritoneal Cancer Index (PCI) Score

  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.

  At time of procedure

Secondary Outcomes (3)

• Completeness of Cytoreduction (CC) Score

  At time of procedure

• Overall Survival

  3 years after procedure

• Recurrence Free Survival

  3 years after procedure

Study Arms (2)

The Christie NHS FT

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.

Procedure: Cytoreduction and Heated Intraperitoneal Surgery

Hampshire Hospitals NHS FT

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.

Procedure: Cytoreduction and Heated Intraperitoneal Surgery

Interventions

Cytoreduction and Heated Intraperitoneal Surgery PROCEDURE

Cytoreductive Surgery is a procedure that aims for the complete removal of all visible tumours affecting the protective lining of the abdomen. After the surgical procedure is completed, the surgeon introduces a heated, sterile solution mixed with chemotherapy drugs into the abdominal cavity (the HIPEC).

Hampshire Hospitals NHS FT; The Christie NHS FT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

200 eligible patients identified from prospective databases located at The Christie NHS Foundation Trust and Hampshire Hospitals NHS Foundation Trust. The first 100 eligible patients from each of these databases who received CRS \& HIPEC for PMCR from the 1st of January 2010 will be selected.

You may qualify if:

• 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

You may not qualify if:

• Under the age of 18
• Palliative patients
• Diagnosed distant metastasis

Sponsors & Collaborators

• University of Manchester: lead
• The Christie NHS Foundation Trust: collaborator
• Hampshire Hospitals NHS Foundation Trust: collaborator
• University Hospital Birmingham: collaborator
• Bowel Disease Research Foundation (BDRF): collaborator

Related Publications (4)

• NICE. Cytoreduction surgery followed by hyperthermic intraoperative peritoneal chemotherapy for peritoneal carcinomatosis. IPG331. 2010.

  BACKGROUND

• McCulloch 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 RESULT

• Verwaal 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 RESULT

• Blazeby 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 RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Cytoreduction Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Andrew G Renehan, PhD

  The University of Manchester

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: March 10, 2016
• Primary Completion: July 5, 2019
• Study Completion: November 30, 2019
• Last Updated: November 29, 2023

Record last verified: 2023-11