AdenocarcinomaMERCURY IINCT02005965
Low Rectal Cancer Study (MERCURY II)
An observational study of Adenocarcinoma and Adenocarcinoma, Mucinous, run by Royal Marsden NHS Foundation Trust at 17 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Adenocarcinoma, Mucinous, Carcinoma
- How many people
- 542 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 13 Aug 2007to 11 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biopsy proven adenocarcinoma within 6cm of the anal verge confirmed on MRI.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United Kingdom14 sites
North Hampshire Hospitals NHS Trust (Basingstoke Hospital)
Basingstoke, Hampshire, RG24 9NA
Ulster Hospital
Belfast, BT16 1RH
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ
Princess of Wales Hospital
Bridgend, Wales, CF31 1RQ
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Croydon University Hospital
Croydon, Surrey, CR7 7YE
Frimley Park Hospital NHS Foundation Trust
Frimley, Surrey, GU16 7UJ
West Middlesex University Hospital
Isleworth, Middlesex, TW7 6AF
Royal Marsden Hospital
London & Surrey
North Manchester General Hospital
Manchester, M8 5RB
Milton Keynes General Hospital
Milton Keynes, Buckinghamshire, MK6 5LD
Salisbury NHS Foundation Trust (Salisbury District Hospital)
Salisbury, Wiltshire, SP2 8BJ
Stepping Hill Hospital
Stockport, Cheshire, SK2 7JE
Weston General Hospital
Weston-super-Mare, Somerset, BS23 4TQ
Germany2 sites
Vivantes Klinikum im Friedrichshain
Berlin, 10249
Krankenhaus Dresden-Friedrichstadt
Dresden, 01067
About this study
Official title: The Low Rectal Cancer Study.
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.
Read the 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.
- Conditions
- Adenocarcinoma, Adenocarcinoma, Mucinous, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms
- Keywords
- Rectal Cancer, Low Rectal Cancer, MERCURY, Cancer, CRM, Circumferential Margin, Quality of Life, MRI, Radiology, Abdominoperineal Excision, Anterior Resection, Surgery, Pathology
- Medical subject headings
- Adenocarcinoma, Adenocarcinoma, Mucinous, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Cystic, Mucinous, and Serous, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Staging and outcomes for patients with Low Rectal Cancer | Low Rectal Cancer defined on MRI as a cancer within 6cm of the anal verge |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the rate of CRM positivity rate in low rectal cancer.
Measured: 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.
Measured: 8 years
Secondary outcomes (6)
To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation.
Measured: 8 years
Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE.
Measured: 8 years
Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery.
Measured: 8 years
Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches.
Measured: 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.
Measured: 8 years
Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study start13 Aug 2007
- Primary completion11 Mar 2016
- Study completion11 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Brown, Principal investigator, Royal Marsden NHS Foundation TrustBrendan Moran, Principal investigator, Pelican Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005965
- Sponsor's protocol ID
- CCR2943
- Acronym
- MERCURY II
- Status last verified
- Sep 2018
- First submitted
- 21 Nov 2013
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25822672
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Low Rectal Cancer Study.
- ClinicalTrials.gov ID
- NCT02005965
- Acronym / sponsor ID
- MERCURY II / CCR2943
- Conditions
- Adenocarcinoma, Adenocarcinoma, Mucinous, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms
- Keywords
- Rectal Cancer, Low Rectal Cancer, MERCURY, Cancer, CRM, Circumferential Margin, Quality of Life, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Study start
- 13 Aug 2007 (actual)
- Primary completion
- 11 Mar 2016 (actual)
- Study completion
- 11 Mar 2021 (estimated)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staging and outcomes for patients with Low Rectal Cancer | – | –Low Rectal Cancer defined on MRI as a cancer within 6cm of the anal verge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy proven adenocarcinoma within 6cm of the anal verge confirmed on MRI.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the rate of CRM positivity rate in low rectal cancer.
Time frame: 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.
Time frame: 8 years
6 secondary outcomes
To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation.
Time frame: 8 years
Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE.
Time frame: 8 years
Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery.
Time frame: 8 years
Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches.
Time frame: 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.
Time frame: 8 years
Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay.
Time frame: 8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Derived from this study: PubMed 25822672Battersby 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Brown principal investigator
Royal Marsden NHS Foundation Trust
Brendan Moran principal investigator
Pelican Cancer Foundation
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma and Adenocarcinoma, Mucinous, run by Royal Marsden NHS Foundation Trust at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Germany, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the rate of CRM positivity rate in low rectal cancer. (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02005965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.