An observational study in Adenocarcinoma, Adenocarcinoma, Mucinous and Carcinoma, sponsored by Royal Marsden NHS Foundation Trust. Status unknown at 17 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-18.
Sponsored by Royal Marsden NHS Foundation Trust · Observational
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.
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.
31 studies on the registry are indexed under Adenocarcinoma, Mucinous; 10 are open to participants now.
Browse Adenocarcinoma, Mucinous studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 273 studies on the registry; 53 are open to participants now.
Compared within Adenocarcinoma, Mucinous, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Adenocarcinoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with biopsy proven adenocarcinoma within 6cm of the anal verge confirmed on MRI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low Rectal Cancer defined on MRI as a cancer within 6cm of the anal verge
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
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
Ran from Aug 2007 to primary completion in Mar 2016, 102 months.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Royal Marsden NHS Foundation Trust →