Low Rectal Cancer Study (MERCURY II)

• Conditions: Neoplasms by Histologic Type; Colorectal Neoplasms; Gastrointestinal Neoplasms; Digestive System Diseases; Adenocarcinoma, Mucinous; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Adenocarcinoma; Neoplasms, Cystic, Mucinous, and Serous

• Registration Number: NCT02005965
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary, multi-centre study. However, there were differences in patient outcome, dependent upon the position of the tumour in the rectum and its height above the anal verge. Whilst the outcome was excellent for patients who underwent an anterior resection, the outcome, based upon margin involvement and quality of the specimen, was poor for patients who underwent an abdomino-perineal excision for low rectal cancer.

It is proposed that accurate MRI staging pre-operatively will allow the correct patients to receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the resection margins appear threatened so that the operation can be modified to take this into account. The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate of CRM positivity rate in low rectal cancer and to assess the difference in global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.

Detailed Description

The aim of this study is to reduce the positive margin rate of 30% to around 15%. The study is an international multicentre, prospective, observational study, whereby patients with biopsy-proven low-rectal cancer (lower edge of the tumour \< 6cms from the anal verge on MRI), will be recruited from participating centres, having given informed, written consent. Data from the radiology, surgical and pathological aspects will be collected and analysed centrally at the Royal Marsden Hospital. The patient's medical records will be reviewed for five years post surgery, and the patients will also be followed up by quality of life questionnaires. This project aims to show that in low rectal cancer, improved local control and survival can be achieved through a reduction in the involved CRM rates by MRI-planned surgery and selective pre-operative therapy. It also aims to assess the ability to predict disease recurrence and to provide an assessment of disease-free survival and overall survival.

Study Timeline

• Study Start: 2007-08-13
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-09
• Primary Completion: 2016-03-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Study Completion: 2021-03-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

• Ability to give informed, written consent.
• Adults age 18 or over - male or female.
• Recently diagnosed with biopsy-proven, primary, low rectal cancer.
• No previous therapy for rectal cancer.

Exclusion Criteria

• Current pregnancy, including ectopic pregnancy.
• Previous pelvic/rectal malignancy (excluding carcinoma in-situ).
• Previous pelvic radiotherapy.
• Previous pelvic floor surgery for faecal incontinence or prolapse.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.	8 years
To assess the rate of CRM positivity rate in low rectal cancer.	4 years

Secondary Outcome Measures

Name	Time	Method
Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches.	8 years
To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation.	8 years
Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE.	8 years
Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery.	8 years
Investigation of potential associations between imaging and pathology assessment of radial and distal margins, neo-adjuvant chemoradiotherapy, perineal complications and sphincter preservation rates.	8 years
Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay.	8 years

Trial Locations

Locations (17)

Salisbury NHS Foundation Trust (Salisbury District Hospital); 🇬🇧 Salisbury, Wiltshire, United Kingdom

Princess of Wales Hospital; 🇬🇧 Bridgend, Wales, United Kingdom

University Hospital of Wales; 🇬🇧 Cardiff, Wales, United Kingdom

North Hampshire Hospitals NHS Trust (Basingstoke Hospital); 🇬🇧 Basingstoke, Hampshire, United Kingdom

Frimley Park Hospital NHS Foundation Trust; 🇬🇧 Frimley, Surrey, United Kingdom

The First Surgical Clinic; 🇷🇸 Belgrade, Serbia

Weston General Hospital; 🇬🇧 Weston-super-Mare, Somerset, United Kingdom

Bradford Royal Infirmary; 🇬🇧 Bradford, West Yorkshire, United Kingdom

West Middlesex University Hospital; 🇬🇧 Isleworth, Middlesex, United Kingdom

Croydon University Hospital; 🇬🇧 Croydon, Surrey, United Kingdom

Royal Marsden Hospital; 🇬🇧 London & Surrey, United Kingdom

Vivantes Klinikum im Friedrichshain; 🇩🇪 Berlin, Germany

Krankenhaus Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

Stepping Hill Hospital; 🇬🇧 Stockport, Cheshire, United Kingdom

Milton Keynes General Hospital; 🇬🇧 Milton Keynes, Buckinghamshire, United Kingdom

Ulster Hospital; 🇬🇧 Belfast, United Kingdom

North Manchester General Hospital; 🇬🇧 Manchester, United Kingdom