Low Rectal Cancer Study (MERCURY II)

NCT ID: NCT02005965

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 542 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-13
• Study Completion Date: 2021-03-11

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.

Conditions

Adenocarcinoma; Adenocarcinoma, Mucinous; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Staging and outcomes for patients with Low Rectal Cancer

Low Rectal Cancer defined on MRI as a cancer within 6cm of the anal verge

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pelican Cancer Foundation

OTHER

Sponsor Role: collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gina Brown

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Brendan Moran

Role: PRINCIPAL_INVESTIGATOR

Pelican Cancer Foundation

Locations

Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Krankenhaus Dresden-Friedrichstadt

Dresden, , Germany

The First Surgical Clinic

Belgrade, , Serbia

Milton Keynes General Hospital

Milton Keynes, Buckinghamshire, United Kingdom

Stepping Hill Hospital

Stockport, Cheshire, United Kingdom

North Hampshire Hospitals NHS Trust (Basingstoke Hospital)

Basingstoke, Hampshire, United Kingdom

West Middlesex University Hospital

Isleworth, Middlesex, United Kingdom

Weston General Hospital

Weston-super-Mare, Somerset, United Kingdom

Croydon University Hospital

Croydon, Surrey, United Kingdom

Frimley Park Hospital NHS Foundation Trust

Frimley, Surrey, United Kingdom

Princess of Wales Hospital

Bridgend, Wales, United Kingdom

University Hospital of Wales

Cardiff, Wales, United Kingdom

Bradford Royal Infirmary

Bradford, West Yorkshire, United Kingdom

Salisbury NHS Foundation Trust (Salisbury District Hospital)

Salisbury, Wiltshire, United Kingdom

Ulster Hospital

Belfast, , United Kingdom

Royal Marsden Hospital

London & Surrey, , United Kingdom

North Manchester General Hospital

Manchester, , United Kingdom

Countries

Germany; Serbia; United Kingdom

References

Battersby NJ, How P, Moran B, Stelzner S, West NP, Branagan G, Strassburg J, Quirke P, Tekkis P, Pedersen BG, Gudgeon M, Heald B, Brown G; MERCURY II Study Group. Prospective Validation of a Low Rectal Cancer Magnetic Resonance Imaging Staging System and Development of a Local Recurrence Risk Stratification Model: The MERCURY II Study. Ann Surg. 2016 Apr;263(4):751-60. doi: 10.1097/SLA.0000000000001193.

Reference Type: DERIVED

PMID: 25822672 (View on PubMed)

Other Identifiers

CCR2943

Identifier Type: -

Identifier Source: org_study_id