Trial record 7 of 5571 for:    Open Studies | "Gastrointestinal Diseases"

Low Rectal Cancer Study (MERCURY II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Royal Marsden NHS Foundation Trust
Sponsor:
Collaborator:
Pelican Cancer Foundation (www.pelicancancer.org)
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02005965
First received: November 21, 2013
Last updated: December 4, 2013
Last verified: October 2012
  Purpose

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.


Condition
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Low Rectal Cancer Study.

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • To assess the rate of CRM positivity rate in low rectal cancer. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To compare global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation. [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE. [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery. [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches. [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Investigation of potential associations between imaging and pathology assessment of radial and distal margins, neo-adjuvant chemoradiotherapy, perineal complications and sphincter preservation rates. [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 495
Study Start Date: September 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Staging and outcomes for patients with Low Rectal Cancer
Low Rectal Cancer defined on MRI as a cancer within 6cm of the anal verge

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005965

Contacts
Contact: Gina Brown 0208 915 3694 gina.brown@rmh.nhs.uk
Contact: Nick Battersby 01256 314746 nick.battersby@nhs.net

Locations
Germany
Vivantes Klinikum im Friedrichshain Recruiting
Berlin, Germany, 10249
Contact: Thomas Goebel       thomas.goebel@cra-freelancer.com   
Principal Investigator: Joachim Strassburg         
Krankenhaus Dresden-Friedrichstadt Recruiting
Dresden, Germany, 01067
Contact: Sigmar Stelzner       Stelzner-Si@khdf.de   
Principal Investigator: Sigmar Stelzner         
Serbia
The First Surgical Clinic Recruiting
Belgrade, Serbia, 11000
Contact: Jelena Petrovic       jelapetrovic@gmail.com   
Principal Investigator: Jelena Petrovic         
United Kingdom
Milton Keynes General Hospital Not yet recruiting
Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
Contact: Stephanie Edwards       Stephanie.Edwards@mkhospital.nhs.uk   
Principal Investigator: Anil Hernandes         
North Hampshire Hospitals NHS Trust (Basingstoke Hospital) Recruiting
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Contact: Nick Battersby    01256 314746    nick.battersby@nhs.net   
Principal Investigator: Brendan Moran         
Weston General Hospital Not yet recruiting
Weston-super-Mare, Somerset, United Kingdom, BS23 4TQ
Contact: Deborah Coles    01934 881377 ext 5049    deborahcoles@nhs.net   
Principal Investigator: Geoff Pye         
Croydon University Hospital Recruiting
Croydon, Surrey, United Kingdom, CR7 7YE
Contact: Yvonne Campbell    020 8401 3000 ext 5661    Yvonne.Campbell@croydonhealth.nhs.uk   
Contact: Ibiyemi Olaleye    020 8401 3000 ext 4761    Ibiyemi.Olaleye@croydonhealth.nhs.uk   
Principal Investigator: Ian Swift         
Frimley Park Hospital NHS Foundation Trust Recruiting
Frimley, Surrey, United Kingdom, GU16 7UJ
Contact: Carrie Burgess    01276 526779    carrie.burgess@nhs.net   
Principal Investigator: David Edwards         
Princess of Wales Hospital Not yet recruiting
Bridgend, Wales, United Kingdom, CF31 1RQ
Contact: Lisa Roche    02920 615888 ext 6701    Lisa.Roche2@wales.nhs.uk   
Principal Investigator: Joanna Hilton         
University Hospital of Wales Not yet recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Zoe Davies    02920746609    Zoe.davies7@wales.nhs.uk   
Principal Investigator: Richard Adams         
Salisbury NHS Foundation Trust (Salisbury District Hospital) Recruiting
Salisbury, Wiltshire, United Kingdom, SP2 8BJ
Contact: Hiliary Dean    01722 336262 ext 2194    Hilary.Dean@salisbury.nhs.uk   
Principal Investigator: Graham Branagan         
Ulster Hospital Recruiting
Belfast, United Kingdom, BT16 1RH
Contact: Ethna McFerran       ethna.mcferran@setrust.hscni.net   
Principal Investigator: Ian McAllister         
Royal Marsden Hospital Recruiting
London & Surrey, United Kingdom
Contact: Lisa Scerri    0208 915 6067    lisa.scerri@rmh.nhs.uk   
Contact: Gina Brown    0208 661 3964    gina.brown@rmh.nhs.uk   
Principal Investigator: Gina Brown         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Pelican Cancer Foundation (www.pelicancancer.org)
Investigators
Principal Investigator: Gina Brown Royal Marsden NHS Foundation Trust
Principal Investigator: Brendan Moran Pelican Cancer Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02005965     History of Changes
Other Study ID Numbers: CCR2943
Study First Received: November 21, 2013
Last Updated: December 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
Rectal Cancer
Low Rectal Cancer
MERCURY
Cancer
CRM
Circumferential Margin
Quality of Life
MRI
Radiology
Abdominoperineal Excision
Anterior Resection
Surgery
Pathology

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Adenocarcinoma
Neoplasms
Carcinoma
Rectal Neoplasms
Adenocarcinoma, Mucinous
Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases
Neoplasms, Cystic, Mucinous, and Serous
Colonic Diseases

ClinicalTrials.gov processed this record on July 29, 2014