Trial Title:
Low Rectal Cancer Study (MERCURY II)
NCT ID:
NCT02005965
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
Conditions: Official terms:
Neoplasms
Adenocarcinoma
Rectal Neoplasms
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Intestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Cystic, Mucinous, and Serous
Adenocarcinoma, Mucinous
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
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
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients with biopsy proven adenocarcinoma within 6cm of the anal verge confirmed on MRI.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Vivantes Klinikum im Friedrichshain
Address:
City:
Berlin
Zip:
10249
Country:
Germany
Facility:
Name:
Krankenhaus Dresden-Friedrichstadt
Address:
City:
Dresden
Zip:
01067
Country:
Germany
Facility:
Name:
The First Surgical Clinic
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Facility:
Name:
Milton Keynes General Hospital
Address:
City:
Milton Keynes
Zip:
MK6 5LD
Country:
United Kingdom
Facility:
Name:
Stepping Hill Hospital
Address:
City:
Stockport
Zip:
SK2 7JE
Country:
United Kingdom
Facility:
Name:
North Hampshire Hospitals NHS Trust (Basingstoke Hospital)
Address:
City:
Basingstoke
Zip:
RG24 9NA
Country:
United Kingdom
Facility:
Name:
West Middlesex University Hospital
Address:
City:
Isleworth
Zip:
TW7 6AF
Country:
United Kingdom
Facility:
Name:
Weston General Hospital
Address:
City:
Weston-super-Mare
Zip:
BS23 4TQ
Country:
United Kingdom
Facility:
Name:
Croydon University Hospital
Address:
City:
Croydon
Zip:
CR7 7YE
Country:
United Kingdom
Facility:
Name:
Frimley Park Hospital NHS Foundation Trust
Address:
City:
Frimley
Zip:
GU16 7UJ
Country:
United Kingdom
Facility:
Name:
Princess of Wales Hospital
Address:
City:
Bridgend
Zip:
CF31 1RQ
Country:
United Kingdom
Facility:
Name:
University Hospital of Wales
Address:
City:
Cardiff
Zip:
CF14 4XW
Country:
United Kingdom
Facility:
Name:
Bradford Royal Infirmary
Address:
City:
Bradford
Zip:
BD9 6RJ
Country:
United Kingdom
Facility:
Name:
Salisbury NHS Foundation Trust (Salisbury District Hospital)
Address:
City:
Salisbury
Zip:
SP2 8BJ
Country:
United Kingdom
Facility:
Name:
Ulster Hospital
Address:
City:
Belfast
Zip:
BT16 1RH
Country:
United Kingdom
Facility:
Name:
Royal Marsden Hospital
Address:
City:
London & Surrey
Country:
United Kingdom
Facility:
Name:
North Manchester General Hospital
Address:
City:
Manchester
Zip:
M8 5RB
Country:
United Kingdom
Start date:
August 13, 2007
Completion date:
March 11, 2021
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Pelican Cancer Foundation
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02005965
