Low Rectal Cancer Study (MERCURY II)

Neoplasms Clinical Trial

— MERCURY II  

Official title:

The Low Rectal Cancer Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02005965
• Other study ID #: CCR2943
• Status: Active, not recruiting
• Start date: August 13, 2007
• Est. completion date: March 11, 2021

Study information

• Verified date: September 2018
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 542
• Est. completion date: March 11, 2021
• Est. primary completion date: March 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Mucinous
• Carcinoma
• 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, Cystic, Mucinous, and Serous
• Neoplasms, Glandular and Epithelial
• Rectal Diseases
• Rectal Neoplasms

Locations

Country	Name	City	State
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Krankenhaus Dresden-Friedrichstadt	Dresden
Serbia	The First Surgical Clinic	Belgrade
United Kingdom	North Hampshire Hospitals NHS Trust (Basingstoke Hospital)	Basingstoke	Hampshire
United Kingdom	Ulster Hospital	Belfast
United Kingdom	Bradford Royal Infirmary	Bradford	West Yorkshire
United Kingdom	Princess of Wales Hospital	Bridgend	Wales
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Croydon University Hospital	Croydon	Surrey
United Kingdom	Frimley Park Hospital NHS Foundation Trust	Frimley	Surrey
United Kingdom	West Middlesex University Hospital	Isleworth	Middlesex
United Kingdom	Royal Marsden Hospital	London & Surrey
United Kingdom	North Manchester General Hospital	Manchester
United Kingdom	Milton Keynes General Hospital	Milton Keynes	Buckinghamshire
United Kingdom	Salisbury NHS Foundation Trust (Salisbury District Hospital)	Salisbury	Wiltshire
United Kingdom	Stepping Hill Hospital	Stockport	Cheshire
United Kingdom	Weston General Hospital	Weston-super-Mare	Somerset

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Pelican Cancer Foundation

Countries where clinical trial is conducted

Germany,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the rate of CRM positivity rate in low rectal cancer.		4 years
Primary	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	To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation.		8 years
Secondary	Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE.		8 years
Secondary	Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery.		8 years
Secondary	Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches.		8 years
Secondary	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
Secondary	Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay.		8 years