NCT02005965

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
542

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
3 countries

17 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2007

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2021

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

8.6 years

First QC Date

November 21, 2013

Last Update Submit

September 17, 2018

Conditions

AdenocarcinomaAdenocarcinoma, MucinousCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Cystic, Mucinous, and SerousColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Keywords

Rectal CancerLow Rectal CancerMERCURYCancerCRMCircumferential MarginQuality of LifeMRIRadiologyAbdominoperineal ExcisionAnterior ResectionSurgeryPathology

Outcome Measures

Primary Outcomes (2)

  • To assess the rate of CRM positivity rate in low rectal cancer.

    4 years

  • 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

Secondary Outcomes (6)

  • 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

  • Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches.

    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

  • +1 more secondary outcomes

Study Arms (1)

Staging and outcomes for patients with Low Rectal Cancer

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with biopsy proven adenocarcinoma within 6cm of the anal verge confirmed on MRI.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Krankenhaus Dresden-Friedrichstadt

Dresden, 01067, Germany

Location

The First Surgical Clinic

Belgrade, 11000, Serbia

Location

Milton Keynes General Hospital

Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom

Location

Stepping Hill Hospital

Stockport, Cheshire, SK2 7JE, United Kingdom

Location

North Hampshire Hospitals NHS Trust (Basingstoke Hospital)

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

West Middlesex University Hospital

Isleworth, Middlesex, TW7 6AF, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, Somerset, BS23 4TQ, United Kingdom

Location

Croydon University Hospital

Croydon, Surrey, CR7 7YE, United Kingdom

Location

Frimley Park Hospital NHS Foundation Trust

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

Princess of Wales Hospital

Bridgend, Wales, CF31 1RQ, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Bradford Royal Infirmary

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Salisbury NHS Foundation Trust (Salisbury District Hospital)

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

Location

Ulster Hospital

Belfast, BT16 1RH, United Kingdom

Location

Royal Marsden Hospital

London & Surrey, United Kingdom

Location

North Manchester General Hospital

Manchester, M8 5RB, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25822672DERIVED

MeSH Terms

Conditions

AdenocarcinomaAdenocarcinoma, MucinousCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Cystic, Mucinous, and SerousColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesRectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases

Study Officials

  • Gina Brown

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Brendan Moran

    Pelican Cancer Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

December 9, 2013

Study Start

August 13, 2007

Primary Completion

March 11, 2016

Study Completion

March 11, 2021

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

GB(14)SE(1)DE(2)