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NCT03733184: IDEAL-PM
Development of an IDEAL Framework to Standardise Cytoreductive Surgery for Colorectal Peritoneal Metastases
trial testing Cytoreduction and Heated Intraperitoneal Surgery in Colorectal Cancer Metastatic in 200 participants. Completed in 30 November 2019.
5 July 2019
Quick facts
| Lead sponsor | University of Manchester |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 10 March 2016 |
| Primary completion | 5 July 2019 |
| Estimated completion | 30 November 2019 |
Drugs / interventions tested
- Cytoreduction and Heated Intraperitoneal Surgery
Conditions studied
- Colorectal Cancer Metastatic — all drugs for Colorectal Cancer Metastatic →
- Peritoneal Metastases — all drugs for Peritoneal Metastases →
Sponsor
University of Manchester
Who can join
Adults 18 to 90, any sex, with Colorectal Cancer Metastatic or Peritoneal Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Current Research and Development in Hyperthermic Intraperitoneal Chemotherapy (HIPEC)-A Cross-Sectional Analysis of Clinical Trials Registered on ClinicalTrials.gov.
Ukegjini K, Guidi M, Lehmann K, Süveg K, et al · · 2023 · cited 7× · PMID 37046587 · DOI 10.3390/cancers15071926
Verify or expand the search:
- PubMed search for NCT03733184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03733184 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Manchester
- Last refreshed: 29 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03733184.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing