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

Summary

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.

Conditions

• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Interventions

PROCEDURE

Primary/Bowel-first Surgery

Patients undergoing primary/bowel-first surgery as part of a staged curative procedure. The liver metastases will be resected in a second planned operation.

PROCEDURE

Liver-first surgery

Patients undergoing liver-first surgery as part of a staged curative procedure. The colorectal primary will be resected in a second planned operation.

PROCEDURE

Synchronous resection surgery

Patients undergoing a synchronous colorectal primary resection and liver resection in a single operation.

PROCEDURE

No surgery

Patients who have no surgery.

Sponsors & Collaborators

• University of Warwick

  collaborator OTHER

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Ajith K Siriwardena, MD, FRCS · Hepatobiliary Surgery Unit, Manchester Royal Infirmary, United Kingdom

• James Mason, DPhil · Durham Clinical Trials Unit, Wolfson Research Institute, Durham University, United Kingdom

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-20

Primary Completion

2017-04-30

Completion

2017-04-30

Countries

• United Kingdom

Study Locations