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Low Rectal Cancer Study (MERCURY II)
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
Conditions: official terms
Adenocarcinoma - Adenocarcinoma, Mucinous - Colorectal Neoplasms - Digestive System Diseases - Digestive System Neoplasms - Gastrointestinal Diseases - Gastrointestinal Neoplasms - Intestinal Diseases - Intestinal Neoplasms - Neoplasms - Neoplasms by Histologic Type - Neoplasms by Site - Neoplasms, Glandular and Epithelial - Rectal Diseases
Conditions: Keywords
Rectal Cancer, Low Rectal Cancer, MERCURY, Cancer, CRM, Circumferential Margin, Quality of Life, MRI, Radiology, Abdominoperineal Excision, Anterior Resection, Surgery, Pathology
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Locations
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Krankenhaus Dresden-Friedrichstadt
Status: Recruiting
Contact: Thomas Goebel - thomas.goebel@cra-freelancer.com
Dresden, Germany
The First Surgical Clinic
Status: Recruiting
Contact: Sigmar Stelzner - Stelzner-Si@khdf.de
Belgrade, Serbia
Milton Keynes General Hospital
Status: Recruiting
Contact: Jelena Petrovic - jelapetrovic@gmail.com
Milton Keynes, Buckinghamshire, United Kingdom
North Hampshire Hospitals NHS Trust (Basingstoke Hospital)
Status: Not yet recruiting
Contact: Stephanie Edwards - Stephanie.Edwards@mkhospital.nhs.uk
Basingstoke, Hampshire, United Kingdom
Weston General Hospital
Status: Recruiting
Contact: Nick Battersby - 01256 314746 - nick.battersby@nhs.net
Weston-super-Mare, Somerset, United Kingdom
Croydon University Hospital
Status: Not yet recruiting
Contact: Deborah Coles - 01934 881377 - deborahcoles@nhs.net
Croydon, Surrey, United Kingdom
Frimley Park Hospital NHS Foundation Trust
Status: Recruiting
Contact: Yvonne Campbell - 020 8401 3000 - Yvonne.Campbell@croydonhealth.nhs.uk
Frimley, Surrey, United Kingdom
Princess of Wales Hospital
Status: Recruiting
Contact: Carrie Burgess - 01276 526779 - carrie.burgess@nhs.net
Bridgend, Wales, United Kingdom
University Hospital of Wales
Status: Not yet recruiting
Contact: Lisa Roche - 02920 615888 - Lisa.Roche2@wales.nhs.uk
Cardiff, Wales, United Kingdom
Salisbury NHS Foundation Trust (Salisbury District Hospital)
Status: Not yet recruiting
Contact: Zoe Davies - 02920746609 - Zoe.davies7@wales.nhs.uk
Salisbury, Wiltshire, United Kingdom
Ulster Hospital
Status: Recruiting
Contact: Hiliary Dean - 01722 336262 - Hilary.Dean@salisbury.nhs.uk
Belfast, United Kingdom
Royal Marsden Hospital
Status: Recruiting
Contact: Ethna McFerran - ethna.mcferran@setrust.hscni.net
London & Surrey, United Kingdom
Status: Recruiting
Contact: Lisa Scerri - 0208 915 6067 - lisa.scerri@rmh.nhs.uk
Start Date
September 2007
Completion Date
December 2020
Sponsors
Royal Marsden NHS Foundation Trust
Source
Royal Marsden NHS Foundation Trust
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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