Low Rectal Cancer Study (MERCURY II)

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT02005965

Collaborator

Pelican Cancer Foundation (Other)

542

Enrollment

Locations

162.9

Anticipated Duration (Months)

31.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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.

Study Design

Study Type:

Observational

Actual Enrollment :

542 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Low Rectal Cancer Study.

Actual Study Start Date :

Aug 13, 2007

Actual Primary Completion Date :

Mar 11, 2016

Anticipated Study Completion Date :

Mar 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Staging and outcomes for patients with Low Rectal Cancer Low Rectal Cancer defined on MRI as a cancer within 6cm of the anal verge

Outcome Measures

Primary Outcome Measures

To assess the rate of CRM positivity rate in low rectal cancer. [4 years]
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 Outcome Measures

To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation. [8 years]
Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE. [8 years]
Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery. [8 years]
Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches. [8 years]
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]
Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay. [8 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Vivantes Klinikum im Friedrichshain	Berlin		Germany	10249
2	Krankenhaus Dresden-Friedrichstadt	Dresden		Germany	01067
3	The First Surgical Clinic	Belgrade		Serbia	11000
4	Milton Keynes General Hospital	Milton Keynes	Buckinghamshire	United Kingdom	MK6 5LD
5	Stepping Hill Hospital	Stockport	Cheshire	United Kingdom	SK2 7JE
6	North Hampshire Hospitals NHS Trust (Basingstoke Hospital)	Basingstoke	Hampshire	United Kingdom	RG24 9NA
7	West Middlesex University Hospital	Isleworth	Middlesex	United Kingdom	TW7 6AF
8	Weston General Hospital	Weston-super-Mare	Somerset	United Kingdom	BS23 4TQ
9	Croydon University Hospital	Croydon	Surrey	United Kingdom	CR7 7YE
10	Frimley Park Hospital NHS Foundation Trust	Frimley	Surrey	United Kingdom	GU16 7UJ
11	Princess of Wales Hospital	Bridgend	Wales	United Kingdom	CF31 1RQ
12	University Hospital of Wales	Cardiff	Wales	United Kingdom	CF14 4XW
13	Bradford Royal Infirmary	Bradford	West Yorkshire	United Kingdom	BD9 6RJ
14	Salisbury NHS Foundation Trust (Salisbury District Hospital)	Salisbury	Wiltshire	United Kingdom	SP2 8BJ
15	Ulster Hospital	Belfast		United Kingdom	BT16 1RH
16	Royal Marsden Hospital	London & Surrey		United Kingdom
17	North Manchester General Hospital	Manchester		United Kingdom	M8 5RB