A5009972599- Maternal and Perinatal Health Interventions
- Cholangiocarcinoma and Gallbladder Cancer Studies
- Endometriosis Research and Treatment
- Pregnancy-related medical research
- Uterine Myomas and Treatments
- Renal cell carcinoma treatment
- Pancreatic and Hepatic Oncology Research
- Health Systems, Economic Evaluations, Quality of Life
- Pregnancy and preeclampsia studies
- Renal and related cancers
- Primary Care and Health Outcomes
- Oral and gingival health research
- Hepatocellular Carcinoma Treatment and Prognosis
- COVID-19 and healthcare impacts
- Ethics in Clinical Research
- Gynecological conditions and treatments
- Chronic Disease Management Strategies
- Multiple and Secondary Primary Cancers
- Maternal and fetal healthcare
- Gallbladder and Bile Duct Disorders
- Cancer Diagnosis and Treatment
- Preterm Birth and Chorioamnionitis
- Diabetes and associated disorders
- Menstrual Health and Disorders
- Child Nutrition and Feeding Issues
Cancer Research UK Clinical Trials Unit
2011-2024
University of Birmingham
2017-2024
Southampton General Hospital
2011
University College London
2011
BackgroundTransarterial chemoembolisation (TACE) is the standard of care for patients with intermediate stage hepatocellular carcinoma, while multikinase inhibitor sorafenib improves survival in advanced disease. We aimed to determine whether TACE progression-free versus placebo.MethodsWe did a multicentre, randomised, placebo-controlled, phase 3 trial (TACE 2) 20 hospitals UK unresectable, liver-confined carcinoma. Patients were eligible if they at least aged 18 years, had Eastern...
4006 Background: Despite improvements in multidisciplinary management, BTC has a poor outcome. Approximately 20% of cases are suitable for surgical resection with 5 year survival < 10%. BILCAP aimed to determine whether capecitabine (Cape) improves overall (OS) compared observation (Obs) following radical surgery. Methods: Patients completely-resected cholangiocarcinoma (CCA) or gallbladder cancer (including liver and pancreatic resection, as appropriate), adequate biliary drainage, no...
PURPOSE The BILCAP study described a modest benefit for capecitabine as adjuvant therapy curatively resected biliary tract cancer (BTC), and has become the standard of care. We present long-term data novel exploratory subgroup analyses. METHODS This randomized, controlled, multicenter, phase III recruited patients age 18 years or older with histologically confirmed cholangiocarcinoma muscle-invasive gallbladder after resection curative intent an Eastern Cooperative Oncology Group performance...
Abstract Objectives To evaluate the clinical effectiveness of long acting progestogens compared with combined oral contraceptive pill in preventing recurrence endometriosis related pain. Design The PRE-EMPT (preventing endometriosis) pragmatic, parallel group, open label, randomised controlled trial. Setting 34 UK hospitals. Participants 405 women reproductive age undergoing conservative surgery for endometriosis. Interventions were a 1:1 ratio using secure internet facility to progestogen...
BackgroundChronic pelvic pain affects 2–24% of women worldwide and evidence for medical treatments is scarce. Gabapentin effective in treating some chronic conditions. We aimed to measure the efficacy safety gabapentin with no obvious pathology.MethodsWe performed a multicentre, randomised, double-blind, placebo-controlled randomised trial 39 UK hospital centres. Eligible participants were (with or without dysmenorrhoea dyspareunia) at least 3 months duration. Inclusion criteria 18–50 years...
Induction of labor is a commonly performed obstetrical intervention. Vaginal prostaglandin E2 (dinoprostone) first-choice agent. Mechanical methods induction are slower in achieving cervical ripening but have lower risk adverse effects.
Abstract Background Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, the UK context, issues be considered before decision use HSD for a trial is finalised, methodological question prioritised by trials community. Methods The PRIMORANT study had three phases. First, an initial workshop was held scope faced trialists when considering whether HSDs outcomes....
BackgroundHeavy menstrual bleeding affects one in four women and negatively impacts quality of life. Ulipristal acetate is prescribed to treat symptoms associated with uterine fibroids. We compared the effectiveness ulipristal levonorgestrel-releasing intrauterine system at reducing burden heavy bleeding, irrespective presence fibroids.MethodsThis randomised, open-label, parallel group phase III trial enrolled over 18 years from 10 UK hospitals. Participants were centrally a 1:1 ratio,...
Abstract Background Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence symptoms following an operation is common. Although hormonal treatment can reduce this risk, there uncertainty about the best option. Objectives To evaluate clinical and cost-effectiveness long-acting progestogen therapy compared with combined oral contraceptive pill preventing recurrence endometriosis-related pain quality life. Design A multicentre, open, randomised trial...
280 Background: BC2001 showed that adding chemotherapy (5FU+MMC) to radiotherapy significantly improved rates of muscle invasive bladder cancer (MIBC) locoregional control (LRC) [James 2012] but reduced high dose volume RT rather than standard did not reduce late side effects [Huddart 2013]. Here we present an update the time event outcomes after a median 10 years follow up. Methods: Under 2x2 partial factorial design, 458 pts were randomised (178) or cRT (182) (CT comparison) and/or stRT...
4125 Background: Biliary tract tumours are relatively rare, accounting for 0.7% of malignant in adults, with approximately 1200 new cases registered each year England and Wales. The 1-year 5-year survival is poor at 22% 9% respectively. Approximately 15-20% suitable surgical resection but the outlook remains 5 years 15%. Most advanced presentation unsuitable resection. Methods: BILCAP a multi-centre prospective, randomised phase III trial investigating role adjuvant chemotherapy oral...
Background: Sunitinib is a tyrosine kinase inhibitor (TKI) targeting tumour angiogenesis in patients with advanced renal cell carcinoma (RCC). Currently no universally agreed model exists correlating the expression of markers success treatment. Patients and Methods: We retrospectively analysed archival tissue for 59 RCC treated sunitinib. The VEGF-A, VEGFR, PDGFββ, PDGFR, CCND1 CA9 was assessed by immunohistochemistry (IHC) correlated overall survival (OS) progression-free (PFS). Results:...
Background Chronic or gestational hypertension complicates approximately 7% of pregnancies, half which reach 37 weeks’ gestation. Early term birth (at to 38 weeks) may reduce maternal complications, cesareans, stillbirths, and costs but increase neonatal morbidity. In the WILL Trial (When Induce Labour Limit risk in pregnancy hypertension), we aimed establish optimal timing for women with chronic who remain well. Methods findings This 50-centre, open-label, randomised trial United Kingdom...
4018 Background: TACE is regarded as the standard of care for patients (pts) with intermediate stage HCC while sorafenib (S) current advanced disease. 2 was designed to determine whether + S improves progression free survival (PFS) compared alone. Methods: Pts were randomised 1:1 continuous (400mg BD) or placebo (P). Inclusion criteria included unresectable, liver confined HCC, patent main portal vein, ECOG PS ≤ 1 and Child Pugh A score. Study drug commenced at randomisation performed 2-5...
To address optimal timing of birth for women with chronic or gestational hypertension who reach term and remain well. Pragmatic, non-masked randomised trial. Inclusion: maternal age ≥16 years, hypertension, singleton pregnancy, live fetus, 36+0–37+6 weeks' gestation, able to give documented informed consent. Exclusion: contraindication either trial arm (e.g., pre-eclampsia another indication at term), blood pressure (BP) ≥ 160/110 mmHg until controlled, major fetal anomaly anticipated...
Background Second trimester miscarriage and preterm birth is a significant global problem. Surgical cervical cerclage performed to prevent pregnancy loss birth. It utilises either monofilament or braided suture. hypothesised that material becomes colonised with pathogenic bacteria causes vaginal dysbiosis, infection failure. Objectives The primary objective of the study was examine effectiveness using suture as opposed on in women requiring cerclage. Design Superiority open randomised...
Introduction Aortic stenosis (AS) is common affecting >13% of adults over the age 75 years. In people who develop symptoms, without valve replacement, prognosis dismal with mortality as high 50% at 1 year. asymptomatic patients, timing intervention less well defined and a strategy watchful waiting recommended. Many, however, may symptoms attribute this to related decline, rather than worsening AS. Timely in severe AS critical, since delayed often results poor outcomes. Proactive...
AimPatients with advanced renal cell carcinoma and poor performance status (PS≥2) are often deemed unsuitable for treatment. The Pazo2 trial aimed to assess tolerability efficacy of pazopanib as first-line treatment in cancer patients ECOG PS2.MethodsPazo2 was a prospective, single arm, open label, multicentre, phase II trial, conducted 26 UK centres. Eligible were aged ≥18 years, or metastatic clear component (aRCC), measurable disease per RECIST Criteria 1.1, PS2. Co-primary outcomes,...
Abstract Background As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here inform post-pandemic methodology. Methods The (internal pilot) paused March 2020, re-opened July and is currently recruiting 37 UK NHS consultant-led maternity units. We evaluated pandemic adaptations made processes surveyed sites for their views of these changes (20 sites, videoconference). Results Despite 88% favouring an...
e16151 Background: The BILCAP study established capecitabine (cape) as adjuvant therapy for patients with curatively resected biliary tract cancer. An unexpected finding was the apparent lack of benefit cape in women. We examine demographics, toxicity and outcome between sexes. Methods: Data were available 210 who received Cape. Toxicities categorized according to National Cancer Institute’s Common Toxicity Criteria Adverse Events, version 3. event data summarised worst grade at patient...
Abstract Background Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. The PRIMORANT study set out to determine when HSD sufficient quality and utility replace bespoke collection, a methodological question prioritised by the trials community. Methods had three phases. First, an initial workshop was held scope issues faced trialists considering whether use HSDs for trial outcomes. Second, consultation...
Background Heavy menstrual bleeding affects one in four women and negatively impacts quality of life. The levonorgestrel-releasing intrauterine system is an effective long-term treatment but discontinued by many due to unpredictable bleeding, or adverse effects. selective progesterone receptor modulator ulipristal acetate used treat symptomatic fibroids efficacy for the symptom heavy irrespective presence fibroids, unknown. Objectives To determine whether more at reducing burden than after...