Clinical trial NCT02005965: Low Rectal Cancer Study (MERCURY II)
Official title: The Low Rectal Cancer Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Keywords: Rectal Cancer
Low Rectal Cancer
MERCURY
Cancer
CRM
Circumferential Margin
Quality of Life
MRI
Radiology
Abdominoperineal Excision
Anterior Resection
Surgery
Pathology
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Pelican Cancer Foundation
First posted: 2013-12-09
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy proven adenocarcinoma within 6cm of the anal verge confirmed on MRI.

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.

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.

Primary outcomes:
measure: To assess the rate of CRM positivity rate in low rectal cancer.
timeFrame: 4 years
measure: To compare global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.
timeFrame: 8 years
Secondary outcomes:
measure: To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation.
timeFrame: 8 years
measure: Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE.
timeFrame: 8 years
measure: Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery.
timeFrame: 8 years
measure: Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches.
timeFrame: 8 years
measure: Investigation of potential associations between imaging and pathology assessment of radial and distal margins, neo-adjuvant chemoradiotherapy, perineal complications and sphincter preservation rates.
timeFrame: 8 years
measure: Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay.
timeFrame: 8 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Friedrichstadt
city: Belgrade
country: Serbia
facility: The First Surgical Clinic
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes General Hospital
state: Buckinghamshire
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
state: Cheshire
city: Basingstoke
country: United Kingdom
facility: North Hampshire Hospitals NHS Trust (Basingstoke Hospital)
state: Hampshire
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
state: Middlesex
city: Weston-super-Mare
country: United Kingdom
facility: Weston General Hospital
state: Somerset
city: Croydon
country: United Kingdom
facility: Croydon University Hospital
state: Surrey
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital NHS Foundation Trust
state: Surrey
city: Bridgend
country: United Kingdom
facility: Princess of Wales Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: West Yorkshire
city: Salisbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust (Salisbury District Hospital)
state: Wiltshire
city: Belfast
country: United Kingdom
facility: Ulster Hospital
city: London & Surrey
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Gina Brown
role: PRINCIPAL_INVESTIGATOR
affiliation: Pelican Cancer Foundation
name: Brendan Moran
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.