1002346 / IMPACT
Identification of Men with a genetic predisposition to prostate Cancer: Targeted Screening in BRCA1/2 mutation carriers and controls – IMPACT (Study due to close 31/12/2018)
1002349 / UK TTP Registry
United Kingdom Thrombotic Thrombocytopenic Purpura Registry: A prospective study of Thrombotic Thrombocytopenic Purpura in the UK (Study due to close 31/12/2018)
1006384 / UKAITPR
Genetics of Endocrine tumours (Study due to close 01/10/2018)
1113483 / UKALL 14
Experiences of People with Copy Number Variants (Study due to close 29/06/2018)
1204623 / Aristotle
A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (Study due to close 29/06/2018)
1205649 / ICON8 and ICON8B – ICON8 Trial Programme
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease (Study due to close 01/07/2019)
1206664 / FAST-Forward
A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s Disease Dementia (The DAYBREAK Study) (Study due to close 31/08/2018)
1207668 / LI-1
Effectiveness of an image analysing algorithm to diagnose melanoma compared to gold standard histological determination (Study due to close 13/07/2019)
1207674 / SEARCH
A population based study of genetic predispositions and gene-environment interactions in cancer (Study due to close 30/09/2018)
1210711 / ESPAC-4
HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men with Advanced Prostate Cancer (Study due to close 31/12/2018)
1210712 / INTERLACE
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU) (Study due to close 01/12/2019)
1301726 / UKALL 2011
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) (Study due to close 30/04/2019)
1303754 / OPTIMA
A Cohort Study To Establish the Prevalence of Mutations in Patients with CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ALL With Detectable BCR-ABL1 Currently Being Treated With First or Subsequent TKI Therapy in the UK Using Next Generation Sequencing (Study due to close 31/01/2020)
1303754b / Optima (Main Trial)
Epidemiological study of BRCA1 and BRCA2 mutation carriers (Study due to close 31/01/2020)
1305779 / Ion
Total thryroidectomy(surgery to remove the thyroid gland) followed by Radioactive Iodine Ablation is the standard treatment for patients presenting with intermediate or high risk well differentiated thyroid cancer. Radioiodine (RAI) is mainly used to eliminate any residual normal thyroid tissue. In a subgroup of patients characterised as having low risk of recurrence there is debate as to whether ablation represents overtreatment. RAI causes many side effects including increased risk of a second primary cancer. Ion will answer the question of whether RAI is necessary for low risk differentiated thyroid cancer patients who already have been offered the other two important modalities of treatment i.e. Total Thyroidectomy and optimal TSH (Thyroid Stimulating Hormone) suppression. Patients who have undergone a total thyroidectomy will be randomised (allocated randomly) into one of two groups by a computer program. One group will receive ablation at an activity of 1.1gbq (Giga Becquerels), the other will not receive ablation. There will be an equal number of patients in both groups.
The study is being funded by Cancer Research UK and has a phase II component to assess whether recruitment is feasible before moving to a phase III study. 570 patients will be recruited for the study. (Study due to close 01/02/2019)
1311856 / RAPPER
Radiogenomics: assessment of polymorphisms for predicting the effects of radiotherapy (Study due to close 31/07/2018)
1402893 / Lung ART
Phase III study comparing post-operative conformal radiotherapy to no post-operative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 involvement (Study due to close 23/05/2018)
1408971 / AML18
AML 18 is the replacement trial for AML16 intensive. The UK sees approximately 2000 new cases of AML being diagnosed each year in adults aged over 60 years. This 1600 patient trial is primarily designed for patients over the age of 60 who are considered fit enough for an intensive chemotherapy approach and will aim to test the effects of adding new treatment agents to commonly used chemotherapy combinations in order to improve patient survival and treatment regimes. The AML18 Trial is available to any patient who has primary or secondary AML as defined by the WHO Classification (excluding Acute Promyelocytic Leukaemia), or high risk Myelodysplastic Syndrome (i.e. >10% marrow blasts) over the age of 60. It is a randomised controlled Phase III trial using a factorial design for maximum efficiency to evaluate two induction options followed by treatment with a small molecule post course 1 and dose intensification for suitable patients.
There are four randomisation comparisons within the trial: The first randomisation will compare standard the chemotherapy schedule Daunorubicin/arac (DA) combined with 1 or 2 doses of Mylotarg in course 1. Following recovery from course 1 patients who fail to achieve CR or are MRD positive by centralised flow cytometry will be randomised to one of three options, either DA chemotherapy, DA chemotherapy plus Cladribine or Flag Ida for up to 2 courses of therapy. Patients who achieve CR after course 1 will be randomised to 1 or 2 further courses of DA chemotherapy. At course 2 all patients will also enter a randomisation to receive AC220 versus no AC220 with or without maintenance. Patients will be eligible for a non-intensive allogeneic stem cell transplant if a suitable HLA matched donor is available The study has been set up by the Haematology Clinical Trials Unit in Cardiff. (Study due to close 20/10/2020)
1411013 / FOCUS 4
Molecular selection of therapy in colorectal cancer: a molecularly stratified randomised controlled trials programme (Study due to close 01/01/2019)
1412029 / IHCAP
Hereditary cancer is an important cause of morbidity and mortality and over the last 20 years, the majority of genes that confer high cancer risk when inherited in a mutated form such as BRCA1, BRCA2 in breast cancer and APC, MLH1, MSH2 in colon cancer have been identified. However there are many men and women who have a strong family history of cancer for whom we cannot provide answers because no mutation is found in known genes. The objective of this study is to use innovative genomic technologies such as exome sequencing and whole genome sequencing in combination with functional assays to identify new candidate genes in individuals and families with a suspected hereditary cancer. (Study due to close 31/05/2020)
1502056 / The Molecular Investigation of Unexplained Anaemias
Our study aims to look for new genes and new mutations causing unexplained anaemias in patients who suffer from an inherited anaemia. We have developed in our diagnostic lab a novel high throughput sequencing test simultaneously looking for mutations in 20+ genes that cause inherited anaemias. Patients whose samples are referred for this test and in whom we identify novel or no mutations are invited to participate in the study. The study uses exome/genome sequencing to find new mutations and genes, and tries to understand what effect these have on developing red blood cells. Because a lot of genetic variation is not disease causing, an important part of the study will be inviting family members to be tested for the mutations so that we can check it is passed down in the family in a way that could explain the inheritance pattern of the condition. The benefits of the study include improving our understanding of what governs blood production, in the hopes of finding new treatments for common acquired causes of anaemia, or to help us develop blood production in the lab, an important goal of transfusion medicine. The research is funded by the Medical Research Council. (Study due to close 30/11/2023)
1503071 / FLAIR
This is a phase III, multicentre, randomised, controlled, open, parallel group trial in patients with previously untreated CLL. (Study due to close 30/01/2020)
1508136 / MCL Biobank Observational Study
Mantle Cell Lymphoma (MCL) is a type of non-Hodgkin’s lymphoma; a cancer of the lymphocytes (white blood cells) that occurs when the growth of these cells is out of control. MCL is a relatively rare, usually aggressive cancer for which there is currently no known cure. Many patients are treated as soon as they are diagnosed because they generally have a poor prognosis. However, our experience tells us that there is a sub-set of patients that have a less aggressive form of the disease. They can remain asymptomatic, sometimes for years. These patients need not be treated with systemic chemotherapy straight away and ‘watching and waiting’ does not affect the outcome at all.
There are currently no tests that can tell us which patients have indolent behaving disease at diagnosis. Knowing this will be really helpful in finding the best way to treat people with this disease in the future. The only way that we can really be sure which type of MCL a patient has, is to observe what happens to them over the next few years. We will collect baseline blood and saliva samples, diagnostic biopsy material and clinical information from patients who are newly diagnosed with MCL. These samples will be stored in a Biobank. After this, patients will not directly be involved as the information we need to collect can be found in the medical notes. We aim to recruit 300 participants over 3 years. Once the study is completed, we will know which patients have indolent MCL and which patients have aggressive MCL. We will then study the stored samples to try to identify and understand the differences between indolent and aggressive forms of MCL. (Study due to close 30/09/2019)
1601198 / Add-Aspirin Trial
A phase III, double blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours (Study due to close 01/08/2021)
1603225 / ACELARATE
Pancreatic cancer remains the most lethal of solid tumours with little progress being made to improve patient outcomes over the past 30 years of research. The incidence in the UK is approximately 9,000 new cases per year and, with a 5 year survival remaining at just 3%, mortality approximates incidence. These dismal outcomes reflect: 1. Advanced stage at presentation such that only a minority of patients are suitable for surgery with curative intent; 2. High rates of recurrence even in those undergoing radical surgery; 3. Limited efficacy of systemic therapies.
Gemcitabine has been a standard chemotherapy for these patients for more than 15 years, but drug resistance is common. Acelarin has been developed to overcome the resistances, which are known to limit the effect of gemcitabine and works by preventing cancer cells from dividing by attacking their DNA (deoxyribonucleic acid) resulting in tumour cell death. Non-clinical and clinical studies have shown that Acelarin is more effective than gemcitabine because it is able to reach cancer cells by passive diffusion, is less easily degraded by the cancer cell, and delivers the monophosphate form of the active agent. The primary purpose of this study is to investigate if Acelarin is more effective than gemcitabine in treating patients with metastatic pancreatic cancer. The study will investigate if Acelarin treatment compared with gemcitabine therapy prolongs the life of patients.
We will also evaluate how Acelarin compared with gemcitabine therapy reduce the effects of pancreatic cancer and investigate the safety of Acelarin. A further objective is to discover if blood and tumour tissue from pancreatic cancer patients contains possible proteins, which predict if treatment with Acelarin is better than using gemcitabine. (Study due to close 31/12/2019)
1604237 / Selpac
A Randomised three-arm, open label, Phase II study of continuous Selumetinib versus continuous or interrupted Selumetinib in combination with weekly Paclitaxel in Metastatic Uveal Melanoma (Study due to close 31/12/2018)
1606262 / Life after prostate cancer diagnosis
Prostate cancer is the commonest cancer in men in the United Kingdom (UK). Its treatment may impact on the quality of life of men and their partners/spouses in many different ways. It is important to measure quality of life outcomes so that services can be tailored to meet their needs.
Our main aims are to: describe the healthrelated quality of life (HRQL) of men with prostate cancer using qualitative (interview) and quantitative (survey) methods; explore if and how their HRQL is associated (crosssectional) or is predicted by (longitudinal) disease, treatment and/or patient characteristics with a view to inform health care policy and service delivery to better meet the needs of such men and their families; describe levels of patient empowerment and undertake preliminary exploration of the interaction between empowerment and HRQL. We plan to survey men in England who are at least 12 months beyond diagnosis (~90,500). Men will be identified through the National Cancer Registration Service (NCRS). We have developed a questionnaire which includes validated questions which have proven to be useful in national and international studies.
We plan to survey several different groups of men. One group will be surveyed on two occasions allowing assessment of change over time. A second group, diagnosed in a later calendar year, will be surveyed to assess any changes in the intervening time. We will also conduct detailed interviews with a sample of men who complete the survey (~100) and spouses/partners (~20).
Through the NCRS we plan to link the data with other information (e.g. Hospital treatment data) to better understand the responses. All work will observe agreed principles of confidentiality, data protection and research ethics governance. We will ensure results are available to men and their partners/spouses, the NHS, social care, voluntary sector organisations and other researchers. (Study due to close 09/02/2018)
1608296 / Hartmann’s procedure versus intersphincteric APE: a prospective study
More than 41 000 new cases of bowel cancer are diagnosed annually in the UK with one third occurring in the rectum. Standard treatment for rectal cancer is an operation that removes the section of bowel containing the tumour, reconnecting healthy bowel to the anal canal. This reconstructive approach allows patients to defecate normally, but is associated with a relatively high rate of perioperative complications (40%) and poor bowel function (50%). Where these risks are unacceptably high (frail patients, multiple comorbidities, poor pelvic floor/anal canal function) alternative non-reconnecting strategies are substituted.
Hartmann’s procedure (HP) has been regarded as the non-reconnecting operation of choice and is technically quite straightforward. Alternatively, another operation called IAPE completely removes all of the rectum and anal canal which is thought to significantly reduce the incidence of serious pelvic infection that may with HP. Some surgeons are reluctant to perform this procedure due to the slightly increased operating time and the risk of the local wound failing to heal.
It is unclear which is the best procedure, and there are no prospective data to guide surgeons. This is a prospective observational study of patients undergoing these two procedures, a formal RCT is not possible at the present time due to uncertainty over patient numbers and feasibility of randomisation. The primary objectives are to establish the use of each procedure and determine the surgical complication rate associated with each. This prospective data may be sufficient to determine the optimal procedure, if not it will be used to inform the design of a larger prospective randomised trial. We will also assess whether patients and surgeons would be willing to recruit to such a study also. The study will incorporate centres from across the UK as well as European and worldwide centres who are also interested in answering this question. (Study due to close 30/06/2019)
1610318 / AML19
In AML19 we will ask a number of specific questions. Is the use of a fractionated Mylotarg (GO) ( 2 doses of 3 mg/m2 used in the ALFA) superior to a single Mylotarg dose (3mg/m2 used in AML15 and 17) when combined with either DA or FLAG-Ida induction chemotherapy; does FLAG-Ida /GO induction (best of AML15) improve survival compared to DA (60mg/ m2 x 3) /GO induction; does the addition of 1 or 2 courses of HDAC consolidation to 2 courses of FLAG-Ida induction improve survival; in patients who do not have a FLT3 mutation does the addition of Ganetespib (using the same dose schedule as AML18) to post course 1 chemotherapy improve survival in patients with good or standard risk AML; in high risk patients or those patients with known poor risk cytogenetics at diagnosis is CPX-351 used at the dose schedule established in the Phase 2 study superior to FLAG-Ida (Study due to close 09/11/2021)
1612350 / INCA
The aim is to determine the efficacy and safety of adding inotuzumab ozogamicin to R-CVP in the first line treatment of diffuse Large B Cell Lymphoma in patients who are not able to receive anthracycline containing immunochemotherapy. The incidence of DLBCL is increasing and with an expanding elderly population,the incidence will continue to rise. Given that about 40% of cases of DLBCL occur in patients aged over 70 and the number of co-mobilities increases with age,research to investigate the optimal treatment of DLBCL in this group of patients is needed. R-CHOP remains the standard of care for the majority of patients with DLBCL,anthracycline use is precluded in a proportion of these patients by a high risk of developing cardiotoxicity,especially congestive cardiac failure.
Currently there is no standard of care for patients who are unfit for anthracycline treatment. It has been routine to omit the doxorubicin from R-CHOP,giving R-CVP instead. However the outcome for patients treated with R-CVP is poor and attempts have been made to replace the doxorubicin with alternative agents. The trial will compare an experimental arm consisting of Inotuzumab Ozogamicin added to the standard immunochemotherapy regimen of rituximab,cyclophosphamide, vincristine and prednisolone (IO-R-CVP) with the control arm of gemcitabine added to the same combination (Gem-R-CVP).Patients will be indentified, consented and treated at sites throughout the UK. All patients will receive a steroid pre-phase.
Those patients who have an ECOG performance status 0-2 after steroid pre-phase will be randomised to either Gem-R-CVP or IO-R-CVP for a maximum of 6 cycles followed by 2 further doses of rituximab. If demonstrated to be efficacious and safe to deliver, the IO-R-CVP regimen will be tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracylin (Study due to close 31/10/2018)
1701365 / The UK National Registry of Chronic Myeloid Leukaemia
The UK National Registry of Chronic Myeloid Leukaemia (Study due to close 14/07/2020)
1702374 / Prepare-ABC
This trial is designed to look at whether an exercise intervention would be beneficial to patients pre and post hospital discharge when undergoing curative colorectal surgery. The trial is multi-centre, single blind (assessors only), 3-arm, randomised, controlled, recruiting colorectal cancer patients at point of diagnosis, within colorectal units in UK hospitals. Colorectal cancer is the fourth commonest cancer in the UK, with 40,000 patients diagnosed per year. The current standard and best-proven treatment for this patient group is a surgical resection, with around 25,000 patients undergoing this procedure per year. A colorectal resection, while offering the best chance of survival, results in significant post operative morbidities (poms). Poms have psychological and health burdens for patients, but also impact greatly on healthcare resources and costs. Cost estimates show that post-surgical complications from colorectal surgery at least double the cost of post-operative care.
Therefore interventions to reduce poms could provide health benefits to patients and significant cost savings to the NHS. The Improving Surgery Outcomes Group (ISOG) have reported a correlation between patient’s level of fitness and post-operative outcomes. Literature also reports that exercise training may improve fitness to a significant level even in the short period available between diagnosis and surgery. The role of pre and post-operative exercise hasn’t been extensively investigated, nor has the effectiveness of professionally supervised versus home based exercise programmes. Exercise advice is not yet routinely given to cancer patients.
This trial will compare standard care alone versus standard care plus supervised hospital based exercise and standard care plus supported home based exercise, undertaken 4 weeks pre-surgery and resuming 6 weeks post-surgery. (Study due to close 01/07/2019)
1703389 / C31004
A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Kα Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer (Study due to close 31/12/2018)
1703390 / CONCEPT
Metastatic breast cancer has several treatment options based on the parameters of the disease. Chemotherapy is one of the standard options in this situation. Recent advances have increased the use of docetaxel chemotherapy in the adjuvant (early) setting of breast cancer. In prostate cancer chemotherapy with Cabazitaxel has shown to be effective in patients with progressive disease after docetaxel chemotherapy. Paclitaxel chemotherapy is a standard first line chemotherapy treatment in metastatic breast cancer. This study will evaluate the efficacy of cabazitaxel chemotherapy in comparison to paclitaxel chemotherapy as first line chemotherapy treatment in metastatic breast cancer. (Study due to close 31/08/2022)
1703394 / Imris
Primary bone and soft tissue sarcomas are rare tumours, collectively accounting for 1% of all malignancies diagnosed in the UK. Radiotherapy plays an important role in the local management of these tumours. Cancer cells are damaged by the radiotherapy, and die, because they are unable to repair themselves. Side effects of radiotherapy result from normal tissue in the area around the cancer being damaged by the xârays. Radiotherapy is always planned to avoid healthy tissue as much as possible. However, cancers can have complicated shapes and it is difficult using the normal techniques to match the shape of the xâray beams to the shape of the cancer.
Imris will look at giving radiotherapy in a way that is different to the way it is normally given to patients with sarcoma, using intensity modulated radiotherapy (IMRT). IMRT is a way of shaping the radiotherapy treatment very closely round the tumour. IMRT is a well-established treatment that has been studied a great deal in other cancer types such as head and neck cancer where it has been shown to reduce side effects of radiotherapy, and some hospitals already use it to treat selected sarcoma patients.
However, IMRT is not considered a routine treatment for sarcoma because it has not yet been tested properly in sarcoma clinical trials to prove that it is better than the usual way of giving radiotherapy. The aim of the imris trial is to understand the benefits of IMRT for sarcoma patients, because we think that it will allow us to treat tumours more effectively, with less side effects. (Study due to close 04/10/2018)
1703398 / CANC – 4658
A non-interventional biomarker study in patients with Non-Small Cell Lung Cancers (nsclcs) of adenocarcinoma tumour histology treated in second line with nintedanib in combination with docetaxel (Study due to close 01/02/2019)
1704403 / TREATT
Patients with cancers of the blood often develop low blood cell counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). But recent studies have indicated that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is a type of drug that is called an antifibrinolytic.
These drugs act to reduce the breakdown of clots formed in response to bleeding. These drugs have been used widely in both elective and emergency surgery and have been shown to decrease blood loss and the use of red cell transfusions. The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet transfusions. Patients will be randomised to receive tranexamic acid (given intravenously through a drip, or orally) or a placebo.
We will measure the rates of bleeding daily using a short structured assessment of bleeding, and we will record the number of transfusions given to patients. (Study due to close 31/08/2019)
1705427 / Head & Neck 5000 Follow Up Study
Head & Neck 5000 is a large observational study of people with head and neck cancer from across the United Kingdom. 5511 people from 76 separate centres were recruited making it one of the largest studies of its kind. The Head & Neck 5000 Follow Up Study aims to collect further outcome data on participants who have been in Head & Neck 5000 for a minimum of three years. (Study due to close 04/08/2018)
1706433 / MUK8
A randomised phase II trial of Cyclophosphamide and Dexamethasone in combination with Ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and bortezomib (Study due to close 01/07/2018)
1708470 / Plasmamatch
The UK plasma based Molecular profiling of Advanced breast cancer to inform Therapeutic Choices (plasmamatch) Trial: A multiple parallel cohort, open-label, multi-centre phase iia clinical trial aiming to provide proof of principle efficacy for designated targeted therapies in patients with advanced breast cancer where the targetable mutation is identified through ctdna screening (Study due to close 30/06/2022)
1708476 / TAMARIN
Effects of Tamoxifen on the Mutant Allele Burden and Disease Course in Patients with Myeloproliferative Neoplasms (Study due to close 31/07/2018)
1708490 / PRIMETIME
Post-operative avoidance of radiotherapy in minimal risk women: patient selection using biomarkers (Study due to close 31/12/2021)
1712540 / CHRONOS-4
A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin’s lymphoma (inhl) – CHRONOS-4 (Study due to close 31/12/2019)
1712541 / Gilteritinib as Maintenance After Induction/Consolidation in CR1 AML (Astellas AML Maintenance Study)
A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission (Study due to close 30/11/2018)
1712542 / PRIMA
This is a double-blind, randomised, placebo-controlled study of Niraparib maintenance treatment in patients with ovarian, primary peritoneal or fallopian tube cancer who have homologous recombination deficiency(HRD). This study is being done to help find out if Niraparib, the study drug, can help delay worsening of cancer among patients who had a good response to previous treatment with a platinum-type chemotherapy drug It is normal for our DNA to be damaged and then repaired every day by the cells in our body. Genetic mutations (changes) in the arrangement of genes are needed in order for DNA to fix itself. This process is called DNA repair.
If this process is not done correctly then cancer may occur. An error-free DNA repair process, known as homologous recombination (HR)is needed to prevent mutations. Homologous recombination deficiency (HRD) is a test that measures whether the repair process is working correctly.Participants may only be eligible for randomisation if they have an HRD-positive tumour. For eligible patients, a tumour sample will be collected and sent to a centralised laboratory for immediate HRD testing. A previously collected tumour sample may be used, but if not available, a new sample will need to be collected
. If a new sample is to be collected, participants will be asked to sign a separate consent. The sample may be sent in advance of the protocol-defined screening period in order to facilitate the screening and enrolment process.
Once a participant is randomised, oral Niraparib 300 mg (3 x 100 mg Niraparib capsules) or placebo will be administered once daily continuously in 28-day cycles. They will continue to take the medication until they reach disease progression. Screening through the first 2 cycles will require 6 visits to the study site and thereafter each visit will take place about 4 weeks from the last visit.
Study duration will last approximately 49 weeks, but patients who are benefitting from treatment will have access to their assigned treatment as long as considered acceptable by their treating physician or until they are discontinued from treatment. (Study due to close 20/07/2018)
1802571 / CR UK Stratified Medicine Pilot study
The Cancer Research UK Stratified Medicine Programme: Pilot Study (Study due to close 31/12/2018)
1802579 / PRAN-16-52 Pracinostat in combination with Azacitidine in Adult AML
Phase III, double-blind, placebo-controlled. multicentre, randomised study of pracinostat in combination with Azacitidine in patients ≥18 years with newly diagnosed acute myeloid leukemia unfit for standard induction chemotherapy (Study due to close 30/11/2019)
1804571 / Open Label Study of Relugolix in Men with Advanced Prostate Cancer
HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men with Advanced Prostate Cancer (Study due to close 20/09/2018)
1805626 / LCH-IV
Langerhans Cell Histiocytosis (LCH) is a rare disorder with highly variable clinical presentation and biological behaviours. It can affect a single system/organ (SSLCH) or multiple systems/organs (MSLCH). Patients with SSLCH of the skeleton, skin or the lymph nodes have an excellent prognosis and may need no, or minimal treatment. MSLCH is unpredictable upon diagnosis, ranging from spontaneous resolution to rapid progression and fatal outcome.
Previous research has shown that combination therapy with vinblastine and prednisolone is effective for MSLCH however more than a third of patients suffer disease reactivation. LCH patients may also suffer permanent consequences including hormone deficiencies, a neurodegenerative syndrome and lung fibrosis. This study aims to improve overall survival, reduce reactivation rates and reduce the permanent consequences. The trial is split into seven strata, designed to tailor treatment based on disease features at diagnosis and on response to treatment.
Stratum I is investigating a prolongation (12 vs. 24 months) and intensification (addition of mercaptopurine) of first line therapy (vinblastine and prednisolone) via a randomisation. In stratum II, the response to a uniform initial second line therapy (prednisolone, cytarabine and vincristine) for those patients without risk organ involvement is studied following a randomised comparison of maintenance therapy with either indomethacin or mercaptopurine and methotrexate.
Stratum III (cladribine/cytarabine based salvage treatment) and stratum IV (reduced intensity haemapoietic stem cell transplant) are single arm studies of second line therapy for those patients with risk organ involvement. Stratum V explores the course and treatment of Central Nervous SystemLCH (CNSLCH). Stratum VI is an observational stratum for SSLCH which does not require systemic treatment at diagnosis. (Study due to close 01/12/2020)
1805629 / ROVA-T Maintenance in SCLC (MERU)
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU) (Study due to close 31/01/2019)
1805632 / National Lung Matrix: Multi-Drug Phase II trial in NSC Lung Cancer
The trial consists of a series of parallel multi-centre single arm Phase II trial arms, each testing an experimental targeted drug in a population stratified by multiple pre-specified actionable target putative biomarkers. The primary objective is to evaluate whether there is a signal of activity in each drug-(putative)biomarker cohort separately. A Bayesian adaptive design is adopted to achieve this objective.
The trial is primarily an enrichment putative biomarker design, including patients who are positive for at least on of the actionable targets included in the trial. Patients who are positive for just one putative biomarker will receive the experimental targeted drug specific for that putative biomarker. Putative biomarkers within each drug cohort have been chosen such that in the majority of cases it is not expected that patients will be positive for two or more putative biomarkers within the same drug.
In the rare situation that patients are positive for two or more putative biomarkers relevant across different drugs, treatment will be allocated in accordance with the following strategy: All amplifications and rearrangements will be treated with targeted agent appropriate to them irrespective of concomitant mutations. This will yield crucial predictive biomarker information; for concomitant mutations decisions will be made by the Chief Investigator on a case-by-case basis and based on close consideration of pathway preference and likely dominance of one signal pathway over another together with any pre-clinical efficacy studies that address the activity of the drugs in the presence of concomitant mutations. (Study due to close 30/09/2018)
1810700 / PLATO
Personalising Anal cancer radiotherapy dose – Incorporating Anal Cancer Trials (ACT) ACT3, ACT4 and ACT5 (Study due to close 31/01/2022)
1901749 / CALLS
A Cohort Study To Establish the Prevalence of Mutations in Patients with CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ALL With Detectable BCR-ABL1 Currently Being Treated With First or Subsequent TKI Therapy in the UK Using Next Generation Sequencing (Study due to close 31/12/2018)
2003/7/145 / NSCCG
National Study of Colorectal Cancer Genetics (Study due to close 30/09/2018)
2003/8/159 / BOCS (Formely FBCS)
Identification and molecular analyses of families with susceptibility to breast and/or ovarian cancer (formerly ‘FBCS – Identification and molecular analyses of families with susceptibility to breast cancer’) (Study due to close 31/12/2020)
604071 / STAMPEDE
Prostate cancers depend upon the male hormone testosterone for their growth. Lowering testosterone levels (either by removing all or part of both testes, or by giving anti-hormone treatment) slows the growth of prostate cancers. This type of treatment is called hormone treatment and is often used when prostate cancers have spread outside the prostate gland. Although hormone treatment is usually successful at stopping the cancer growing for a period of time, the cancer will begin to grow again in most men.
There are increasing numbers of treatments available for advanced prostate cancer. These treatments are usually used in prostate cancer when hormone treatment is no longer effective and the cancer has started to grow again.
The aim of this trial, which is called STAMPEDE, is to assess some of these treatments, given earlier in the course of the disease in combination with hormone treatment. The treatments currently assessed in the trial are: Radiotherapy to the prostate; Abiraterone and enzalutamide combination Treatments previously assessed but now closed to recruitment; Zoledronic acid, Docetaxel, Celecoxib and Abiraterone alone. (Study due to close 31/12/2020)
701001 / UK Genetic Prostate Cancer Study
UK Genetic Prostate Cancer Study (formerly the Familial Prostate Cancer Study) (Study due to close 31/12/2022)
912327 / HOPON
A Randomised Controlled Trial of Hyperbaric Oxygen to prevent Osteoradionecrosis of the Irradiated Mandible. To determine the benefit of HBO in the prevention of osteoradionecrosis (ORN) subsequent to a surgical procedure in the “at risk” irradiated mandible.
Questions in a number of key areas will be addressed by this trial:
1. Incidence of ORN in at risk procedures without HBO – published rates vary between 0 and 30%; 2. Outcome of ORN cases without HBO; 3. Benefit of HBO: 4. Morbidity of HBO: measurement of adverse events in treatment arm related to hyperbaric oxygen treatment; 5. Acceptability of Randomisation: to determine if clinicians / patients consent to recruitment for a HBO randomised control trial. (Study due to close 28/02/2018)