POUT is a multi-centred randomised controlled phase III trial. 345 patients who have undergone nephro-ureterectomy, are surgically staged pT2-pT4, N0-3 or are pT1 and node positive, and who are fit for adjuvant chemotherapy, will be randomised to four cycles of adjuvant platinum based chemotherapy (experimental group) or surveillance (control group). Participants will be followed up according to routine practice.
To assess whether regular aspirin use after standard cancer therapy prevents recurrence and prolongs survival in patients with early stage common solid tumours. International recruitment will allow assessment of the intervention in different communities.
The aim of this study is to investigate whether dysphagia optimised intensity modulated radiotherapy (Do-IMRT) compared to standard IMRT (S-IMRT) improves post radiotherapy swallowing difficulties in patients with head and neck cancer.
Incisional hernias are a common complication of abdominal surgery and can be defined as gaps in the wall through which abdominal contents can come through. They can cause patients significant pain, affect body image and also complications, including further major abdominal surgery. This study aims to compare two methods of closing abdominal wounds in the midline. There is the traditional technique of mass closure, involving all layers of the abdominal wall being closed symmetrically at regular points along the wound, and the Hughes repair, which involves closing all layers of the abdominal wall being closed at regular points in a near and far distribution (i.e two sutures close to the midline and two sutures further apart). The idea of the Hughes repair is to distribute tension of the suture closing along different points in the wound and therefore reducing the rate of ‘cut through’ and development of hernias.
Study of tumour focused radiotherapy for bladder cancer (1612348)
A Randomised phase II trial of Adaptive Image guided standard or Dose Escalated tumour boost Radiotherapy in the treatment of transitional cell carcinoma of the bladder.
The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based chemotherapy.
There is no standard of care for the treatment of this group of patients. If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline (R-CHOP).
The drugs being evaluated in this study are MLN0128 and MLN1117. MLN0128 is being evaluated as a single agent and in combination with paclitaxel or MLN1117 to treat women with advanced, recurrent, or persistent endometrial cancer. This study will evaluate the efficacy and safety of each drug or drug combination.
Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer (1703390)
This is a prospective multicentre, randomised, open label, study comparing the efficacy and the safety of six 3-weekly cycles cabazitaxel versus 18 x weekly paclitaxel given as first line chemotherapy treatment in patients with HER2-normal metastatic breast cancer. Randomisation will be conducted by a 1:1 ratio.
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.
Prostate cancers need the male hormone testosterone to grow. Hormone treatments work by stopping testosterone from reaching prostate cancer cells. There are different types of hormone treatments but the most common are injections or implants that work by stopping the testicles making testosterone. Some men will have an operation to remove a part or all of the testicles instead. This type of treatment is called hormone treatment or androgen deprivation therapy (ADT) and it is part of the current standard approach to the treatment of locally advanced or metastatic prostate cancer. In addition, radiotherapy to the prostate and or docetaxel chemotherapy may be recommended as part of the current standard-of-care.
This study will evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy.
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia (1704403)
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.
International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study (1802590)
BREAKOUT is a biomarker research study to help understand how common certain types of genetic mutations in cancer related genes are in patients with breast cancer that has spread (metastatic). The genes analyzed are called breast cancer susceptibility genes (BRCA1 and BRCA2), and mutations on those genes may make some patients more likely to have breast cancer.
Participants must been diagnosed with a type of breast cancer known as metastatic human epidermal growth factor receptor 2 negative (HER2-negative breast cancer) and must have recently began chemotherapy (within the last three months).
To investigate in a randomised trial whether additional short-course chemotherapy given on a weekly schedule immediately before standard chemoradiation leads to an improvement in overall survival in patients with locally advanced cervical cancer.
IoN is a phase II/ III trial that will look to ascertain whether or not radio-iodine ablation is necessary for low risk differentiated thyroid cancer patients.
A Study of IMRT in Primary Bone and Soft Tissue Sarcoma (1703394)
IMRiS is a phase II trial which aims to assess the feasibility, efficacy and toxicity of Intensity Modulated Radiotherapy (IMRT) in three different cohorts of patients with primary bone and soft tissue sarcoma and to demonstrate whether IMRT can improve on current clinical outcomes.
COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease.
Myeloma XII (ACCoRd trial) (1706435)
Myeloma XII (ACCoRd): A phase III study to determine the role of ixazomib as an augmented conditioning therapy in salvage autologous stem cell transplant (ASCT) and as a post-ASCT consolidation and maintenance strategy in patients with relapsed multiple myeloma.
FAST FORWARD – To Identify A 5-Fraction Schedule Of Curative Radiotherapy Delivered In 1 Week That Is At Least As Effective And Safe As The Current UK Standard 15-Fraction Regimen Delivered Over 3 Weeks Following Primary Surgery For Early Breast Cancer.
The main purpose of the study is to determine how normal, common genetic variation affects cancer risk. We hope to achieve this by collecting a blood sample and information on family history and lifestyle from men and women in East Anglia who have been diagnosed with specific cancers.
The purpose of the National Study of Colorectal Cancer Genetics is to collect information from individuals who have been diagnosed with colorectal cancer who also have a family history of the condition, so that we can try and identify new hereditary factors (genes) that may lead to the development of colorectal cancer and further increase our understanding of why this condition develops and perhaps provide new targets for chemotherapy.
A randomised, three arm, open label, phase II study comparing continuous single agent Selumetinib to combination paclitaxel and selumetinib in either a continuous or intermittent schedule.
A phase II randomised study evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in postmenopausal women with ER+ primary breast cancer.
ICON8 and ICON8B (1205649)
Standard first line chemotherapy is a combination of two drugs: carboplatin and paclitaxel, given once every 3 weeks for 6 cycles. However, giving these agents weekly may be more effective; this is called dose-fractionated chemotherapy. In ICON8 two dose-fractionated chemotherapy regimens are compared with standard carboplatin-paclitaxel.
Standard care treatment for Acute Myeloid Leukaemia (AML) patients over the age of 60 not fit for intensive chemotherapy may be improved upon either in combination with novel agents or by use of novel agents alone
To investigate if combination chemotherapy (gemcitabine and capecitabine), when used as adjuvant therapy in patients following resection for pancreatic adenocarcinoma, improves survival over adjuvant therapy using gemcitabine alone.
The OPTIMA trial seeks to advance the development of personalised medicine in breast cancer by using multi-parameter tests to identify those women who are likely to benefit from chemotherapy and sparing those who are unlikely to benefit from an unnecessary and unpleasant treatment.
A Trial for Older Patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.
Molecular selection of therapy in colorectal cancer: a molecularly stratified randomised controlled trials programme.
The trial aims to provide evidence for the future first-line treatment of CLL patients by assessing whether IR is superior to FCR in terms of progression-free survival.
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome.
The aim of this study is to investigate whether an exercise intervention would be beneficial to patients pre and post hospital discharge when undergoing curative colorectal surgery.
The aim of this study is to test whether radiotherapy can be safely avoided in a patient population considered to have such a low risk of local recurrence that the potential absolute gain from radiotherapy is so small as to not outweigh the established risks associated with breast radiotherapy.
The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.
The purpose of this study is to determine the benefit and safety of relugolix 120 mg orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (<=50 ng/dL [1.7 nmol/L] in patients with androgen-sensitive advanced prostate cancer.