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ADD-ASPIRIN Miss Sunita Shrotia |
Add-Aspirin is a large randomised clinical trial, which is taking place in the UK and India. It will recruit 11,000 participants to help find out whether regular aspirin use after treatment for patients with early stage colorectal, breast, prostate and gastrointestinal cancers can prevent the cancer from coming back and preventing deaths. Aspirin is a common painkiller drug that doctors use to prevent heart attacks and stroke in some people. The results of research into using aspirin to prevent heart attacks or strokes has suggested that people who take aspirin regularly are less likely to develop cancer and if they do it is less likely to spread. |
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ARISTOTLE (in follow-up) Dr Sharadah Essapen |
This is a two-arm phase III multicentre randomised controlled interventional trial. Some patients with rectal cancer benefit from receiving chemotherapy and radiotherapy before they have an operation to remove their cancers. This trial will determine whether the addition of a second drug (irinotecan) to the standard treatment of oral chemotherapy using capecitabine and radiotherapy will result in fewer cancer recurrences (regrowth) after the operation and if patients live longer. |
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CIPHER (in follow-up) Mr Philip Bearn |
Around 20,000 people each year have an operation to form a stoma. This is a procedure to divert faeces away from the gastro-intestinal tract (bowel) and is usually required if the bowel becomes damaged either by injury or disease. Most patients who have this operation have a good recovery and are able to manage their stoma well. However, a small number of patients develop a complication called a parastomal hernia (PSH). This is a bulge that develops under or near the stoma, which is caused by weakening of the muscles in the tummy. Unfortunately, we do not know why some patients develop a parastomal hernia and others do not but we think it may be related to how the stoma is formed. This research aims to find out which surgical factors are linked with parastomal hernias by simply collecting details about a patient’s surgery and recovery to better understand why some patients develop parastomal hernias and others do not. This information will be very useful to the NHS and future patients. |
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NeoART Mr Pasha Nisar |
The NeoART trial is for patients with bowel cancers that has not spread to other organs and who are waiting for an operation to remove their cancer. The aim is to determine whether taking a 2 week course of oral Artesunate 200mg daily prior to surgery can improve survival rates and reduce the risk of the cancer coming back after surgery by comparing two groups of patients: those who take the Artesunate with those who took a matching placebo (dummy pill). Artemisinins like Artesunate are used worldwide as part of the treatment for malaria. They come from a plant called sweet wormwood and have been used in traditional Chinese medicines. A small pilot feasibility study in 20 patients conducted at St Georges Hospital in London showed that pre-operative Artesunate was well tolerated. There were also fewer cancer recurrences in the group assigned to Artesunate treatment compared with the placebo. |
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PERSEPHONE (in follow-up) Dr May Teoh |
We invite you to take part in this trial because you have recently been diagnosed with breast cancer which has high levels of HER-2. This is called HER-2 positive breast cancer. HER-2 occurs on the surface of some cells and makes the cells divide and then grow. Trastuzumab (Herceptin®) is a protein treatment (monoclonal antibody) which blocks the normal action of HER-2, and can help reduce the risk of cancer returning. Persephone is an academic trial which aims to establish what is the best length of trastuzumab treatment for patients with Her2+ breast cancer. The optimum trastuzumab duration has not yet been determined as when the drug was first manufactured there was no obvious scientific argument for administering it for 12 months. A large international trial has recently shown no difference in benefit between 12 and 24 months so more isn’t necessarily better. Researchers in another large trial have failed to show that 12 months is better than 6 months. Further analyses are on-going and, although 12 months remains the current standard of treatment, it may well be that the benefit comes from the first 6 months of trastuzumab. The purpose of the PERSEPHONE trial is to confirm whether shorter treatment with trastuzumab for 6 months is as clinically effective and better tolerated than 12 months. |
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POSNOC (In follow- up) Mr Manish Kothari |
This trial is looking at treatment to the armpit after surgery to remove early stage breast cancer. The trial is for women whose breast cancer has spread to 1 or 2 lymph nodes. If the cancer has started to spread, patients will have to have chemotherapy, hormone therapy or both. Currently patients will also have treatment to the lymph nodes in the armpit which could involve more surgery or radiotherapy to the lymph nodes. But it isn’t clear if having treatment to the lymph nodes is useful or necessary as drug treatments are more advanced and very good at preventing the cancer from coming back. Researchers want to compare women who have treatment to the lymph nodes in their armpit with women who don’t. |
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PQIP Mr Mark Macgregor |
The NHS is committed to improving the quality of patient care. However, we know that standards and outcomes can vary between organisations – which means that while some providers may be struggling to deliver best care, others are achieving great results, and we can all learn from how they do this. The Perioperative Quality Improvement Programme (PQIP) is a novel system which will measure and improve patient outcomes after major surgery. Using an innovative but evidence-based approach, we will support clinicians in delivering high quality perioperative care, through the use of data and shared learning. |
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TRACER- X Dr Muthuveni Ezhil |
The TRACERx (TRAcking Cancer Evolution through therapy (Rx)) lung study is a multi-million pound research project taking place over nine years, which will transform our understanding of non-small cell lung cancer (NSCLC) and take a practical step towards an era of precision medicine. In addition, it will use a whole suite of cutting edge analytical techniques on these patients’ tumour samples, giving unprecedented insight into the genomic landscape of primary and metastatic tumours and the impact of treatment upon this landscape. The primary objectives will define the relationship between intratumor heterogeneity and clinical outcomes following surgery and adjuvant therapy as well as establish the impact of adjuvant platinum-containing regimens upon intratumor heterogeneity in relapsed disease compared to primary resected tumour. |
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IMPARTER 4 Dr May Teoh |
The primary aim of the study is to determine if provision of a patient information film about Oncotype DX or Prosigna improves patients’ knowledge and understanding about GEP tests and risk of recurrence results. To examine:-
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POETIC (In follow-up) Mr Tayo Johnson |
Trial of Perioperative Endocrine Therapy – Individualising Care (POETIC) To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI) followed by standard adjuvant therapy improves outcome compared with standard adjuvant therapy alone in postmenopausal women with hormone receptor positive breast cancer. To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting AI therapy will predict for time to recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67 value. To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts for long-term outcome in postmenopausal women with hormone receptor positive breast cancer better than at diagnosis. |
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GenOMICC Dr Ian White |
To establish a prospective DNA resource for hypothesis-testing and genome-wide discovery of host genetic variants underlying susceptibility to severe infection, and outcome from life-threatening systemic injury. We will: Obtain a single DNA sample from patients with:
Obtain DNA from the parents of patients with extreme susceptibility to infection (those under 40 and free from significant comorbidity). Obtain DNA samples, where possible, from appropriate comparison or control groups. Combine existing DNA resources in a virtual collaborative network to enable rapid hypothesis-testing of candidate variants Establish and continually replenish a small cohort of individuals with known profound susceptibility to specific pathogens, who will be invited to provide repeat samples for in vitro studies of cellular responses to relevant stimuli. Where appropriate and implementable, allow return of clinically relevant information to the NHS (or appropriate healthcare provider) regarding participants. Allow lifetime linkage (and beyond) to healthcare and other relevant data (including registries, healthcare records, research datasets, and lifestyle and other data). |
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SIGNET Dr Pardeep Gill |
Statins for Improving orGaN outcomE in Transplantation A multi-centre, single-blind prospective, group sequential, randomised controlled trial to evaluate the benefits of a single dose of Simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients |
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REMAP-CAP Dr Ian White |
Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an Intensive Care Unit (ICU) is associated with substantial mortality. All patients with severe pneumonia who are treated in an ICU will receive therapy that consists of a combination of multiple different treatments. For many of these treatments, different options are available currently. For example, several antibiotics exist that are active against the microorganisms that cause pneumonia commonly but it is not known if one antibiotic strategy is best or whether all suitable antibiotic strategies have similar levels of effectiveness. Of all the treatments that clinicians use for patients with severe CAP, only a small minority have been tested in randomized controlled trials to determine their comparative effectiveness. As a consequence, the standard treatments that are administered vary between and within countries. Current conventional clinical trials methods to assess the efficacy of treatments for pneumonia generally compare two treatment options (either two options for the same treatment modality, where both are in common use; or a new treatment against no treatment or placebo where the effectiveness of the new treatment is not known). Using this approach, in a series of separate and sequential trials, it will take an inordinate length of time to study all the treatment options. Additionally, with conventional trial designs it is not possible to evaluate interactions between treatment options. |
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IMPACT Mr Ali Narvani |
The purpose of this study is to find out if the marketed REGENETEN™ Bioinductive Implant is better than standard repair techniques for surgically treating partial-thickness rotator cuff tears. Smith+Nephew is the company paying for the study and REGENETEN is one of their products. Patients who take part in this study will be randomly assigned to one of two surgical treatments (REGENETEN or a standard surgical repair technique). There is 50:50 chance of being assigned to either treatment type. This is a blinded study so you will not be told which treatment you had until you have completed your time in the study. This is to make sure there is no bias in the data that is being collected. |
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ATNEC Miss Anneliese Lawn |
The primary objectives are to assess whether, omitting further axillary treatment (either ALND or ART) for patients with early-stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no evidence of residual cancer in the lymph nodes on SNB, is non-inferior to axillary treatment in terms of disease free survival (DFS), and reduces the risk of lymphoedema at five years. Secondary objectives are:
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CHRONOS (in follow-up) Mr Nimalan Arumainayagam |
To deliver an overarching RCT framework to efficiently evaluate novel surgical techniques in the treatment of non-metastatic prostate cancer CHRONOS-A Pilot: To determine if men will agree to participate in an RCT that randomly assigns them to focal therapy alone or radical therapy (radiotherapy or prostatectomy). Main: To determine if focal therapy alone is non-inferior when compared to radical therapy (radiotherapy or surgery) in terms of progression-free survival (PFS) at 5 years in men with clinically significant non-metastatic cancer. CHRONOS-B Pilot: To determine if men expressing a preference for focal therapy will agree to participate in a multi-arm, multi-stage (MAMS) RCT that randomly assigns them to focal therapy alone or focal therapy in combination with neoadjuvant and/or adjuvant agents. Main: To determine if focal therapy combined with neoadjuvant and/or adjuvant agents, compared to focal therapy alone, will improve failure-free survival (FFS) at 5 years, in men with clinically significant non-metastatic cancer |
