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Clinical trialNCT02456285CompletedObservational

Colorectal Cancer With Liver-limited Synchronous Metastases: an Inception Cohort Study of Standardised Care Pathways

SponsorManchester University NHS Foundation TrustEnrollment123Colorectal NeoplasmsLiver NeoplasmsNeoplasm Metastasis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background When first diagnosed, colorectal cancer has already metastasized in about 20% of patients to the liver or further (termed synchronous disease). For patients with metastatic disease limited to the liver, major surgery to resect both the primary colorectal cancer and the liver metastasis provides 5-year survival rates of 25-40%. Conventional surgery removes the colorectal primary first, followed by adjuvant chemotherapy, and then resection of the liver metastasis. Surgical advances make synchronous resection (removing both primary and liver metastasis together) and liver-first resection possible. Currently, there is no conclusive evidence to show which approach improves morbidity or survival, and therefore there is no optimum clinical pathway. Treatment is decided at multidisciplinary team (MDT) meetings and is dependent on multiple factors: cancer staging, patient health and preferences, and clinical experience. Methods "Colorectal cancer with Synchronous liver-limited hepatic Metastasis: an Inception Cohort (CoSMIC)", will consent and recruit patients with a new diagnosis of synchronous colorectal cancer limited to the liver. Patients will be recruited at Manchester Royal Infirmary (a National Health Service (NHS) regional cancer-network approved Hepato-pancreato-biliary specialist centers over 2 years using standardized data collection. The sequence of treatment received by each patient, and factors influencing treatment decisions, will be recorded and evaluated against European Society of Medical Oncology guidelines. The effect of surgery on patient quality of life, morbidity, mortality and the long-term outcome will be measured and compared for different treatment sequences adjusted for prognostic factors. Anticipated Outputs and Value of Findings Direct comparison of conventional and new surgical sequences will be explored. Patient engagement, use of standardised recording, identifying common clinical patterns and decision making, and understanding sources of variation are essential steps to develop a definite randomized control trial to resolve the optimal clinical pathway.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Ajith K Siriwardena, MD, FRCS

    Hepatobiliary Surgery Unit, Manchester Royal Infirmary, United Kingdom

    Principal Investigator
  • James Mason, DPhil

    Durham Clinical Trials Unit, Wolfson Research Institute, Durham University, United Kingdom

    Study Director

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United Kingdom
  • Manchester Royal Infirmary

    Manchester, United Kingdom

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
20 May 2015
Primary completion
30 Apr 2017
Completion
30 Apr 2017
Last update posted
16 Mar 2021
Registered enrollment
123
Registry id
NCT02456285

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.