here you go

Search Results

You searched for 'GCP'. Your search returned 24 results.

We are recruiting: Nottingham University Hospitals Research and Innovation Quality Assurance/GCP Auditor

Do you wish to make a difference to research in the NHS? An opportunity has arisen for a Quality Assurance/GCP Auditor to join the Research and Innovation Department at Nottingham University Hospitals (NUH) NHS Trust.
NUH has identified excellence in research … Continue reading

Vacancy: NUH R&I Quality Assurance / GCP Manager, extended to 16th September

NUH R&I seeks to appoint a QA/GCP Manager to assure the quality of clinical research undertaken within Nottingham University Hospitals NHS Trust in accordance with legislative and best practice requirements. This is a key role in the co-ordination of working practices, policy implementation and preparation for external audits and MHRA inspection. Continue reading

A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.

This trial involves patients with advanced prostate cancer. This trial will compare a group on hormone tablets alone with a group on combination of hormone tablets and a radioactive substance. This trial is supported by the European Organisation for Research and Treatment of Cancer (EORTC).

Doctors often treat advanced prostate cancer with a hormone therapy injection or on rare occasions by removal of both testicles. Both these treatments usually stop working after 13 to 22 months. This trial will
recruit these men whose prostate cancer is no longer responding to hormone injections or removal of testicles. Prostate cancer often spreads to bones and more than 90% of men with advanced prostate cancer have secondary cancer in their bones at this stage. Cancer that has spread to the bones can cause significant pain. The secondary cancer in bone significantly affects the men’s ability to enjoy life.

Radium 223 is a new type of radioactive injection. Radium 223 specifically targets cancer cells in the bones. Radium 223 spares lot of normal body tissues and lose its radioactivity very quickly. Radium 223 is safe to use and is already approved for use in advanced prostate cancer in UK and Europe. Enzalutamide is also a newly licensed hormone therapy tablet that is proven to work in patients after the first hormone injection has failed to work.

This trials aims to find out
>> if men having Enzalutamide tablets in combination with Radium 223 injection have longer duration of cancer control in bones compared to men having Enzalutamide tablets alone;
>> if men having the combination treatment live longer, have less bone complications, better pain control and have a better quality of life.
The trial also aims to collect the safety information in men having Radium 223 injections in combination with Enzalutamide tablets and in men having Enzalutamide tablets alone.

Inclusion criteria:
♦Histologically confirmed diagnosis of prostate adenocarcinoma
♦ Asymptomatic or mildly symptomatic (defined as no opioids and Brief Pain Inventory score, i.e. short form question #3 worst pain must be 25 g/L
♦ Normal cardiac function according to local standard by 12-lead ECG (complete, standardized 12-lead recording).
♦ Able to swallow the study drug and comply with study requirements
♦ Prior or concomitant therapy.
-Prior docetaxel is permitted under the following conditions: started within 2 months of ADT initiation, given for a maximum of 6 cycles and progression after 6 months of the last dose of docetaxel.
-Previous treatment with bicalutamide, flutamide, prednisone, or dexamethasone is allowed if it was stopped at least 4 weeks prior to randomization.
♦ Patients taking bisphosphonates or denosumab are eligible if they have received a stable dose for 4-weeks or more prior to randomization. (These treatments may then be continued on study).
♦ Drugs known to lower the seizure threshold or prolong QT interval are not permitted.
♦ Participants who have partners of childbearing potential must use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after last dose of enzalutamide and 6 months after the last dose of Ra223. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
♦ Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
♦ For participation in translational research, specific consent must be given.

Exclusion criteria:
♦ Known central nervous system metastases or leptomeningeal tumor spread.
♦ Significant cardiovascular disease including:
-Myocardial infarction within 6 months prior to screening.
-Uncontrolled angina within 3 months prior to screening.
-Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multigated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
-History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation,torsades de pointes).
-History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
-Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 millimeters of mercury (mm Hg) or diastolic blood pressure > 105 mm Hg at screening.
-Hypotension as indicated by systolic blood pressure Principal Investigator for this trial: Dr Santhanam Sundar

Research Ethics Committee Reference: 16/EM/0017

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

Regulatory and Operational Changes to Clinical Research in the EU

A new EU Clinical Trial Regulations, the prospect of new EU medical device legislation, and changes to the European and national clinical trial authorisation processes will transform the regulatory environment in industry and the public sector. These are welcomed changes … Continue reading

A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses Empagliflozin as Adjunctive to insulin over 52 weeks in patients with Type 1 Diabetes Mellitus (EASE-2)

This is a Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to insulin therapy over 52 weeks in patients with Type 1 Diabetes Mellitus (known as the EASE-2 study).

The study will be conducted at about 135 study clinics/ hospitals worldwide. About 1440 patients will be screened for suitability and about 720 patients will go on to receive the study medication, with 240 patients assigned to each of the three treatment groups: Empagliflozin 10 mg, Empagliflozin 25 mg and Placebo.

Patients will be required to attend 16 scheduled clinic visits and one telephone visit over approximately 64 weeks. Each visit will take 1-2 hours to complete, depending on what has to be done. Recruitment is competitive. This study is
divided into 5 parts:

i. Screening Period (Visit 1): to determine if the patients are eligible
ii Therapy Optimisation Period (Visits 24T): This period lasts for 6 weeks during which the patient’s current treatment approach will be optimised.
iii. Placebo Run-in Period (Visit 5): in this 2 week period, all patients will take two placebo tablets The tablets will be
taken in addition to insulin.
iv. Randomised Treatment Period (Visits 616):
during this 52 week period, patients will receive study medication, either Empagliflozin or placebo, in addition to their insulin.
v. Follow-Up Period (Visit 17): 3 weeks after the patient has stopped taking the study drug, they will return for a final visit.

Inclusion criteria:
1. Signed and dated written informed consent by the date of Visit 1 in accordance with Good Clinical Practice (GCP)
and local legislation
2. Male or female patient receiving insulin for the treatment of documented diagnosis of T1DM for at least 1 year at the
time of Visit 1
3. Fasting C-peptide
value of 0.3% between Visit 1 and Visit 5
6. Based on the Investigator’s judgement patient must have a good understanding of his/her disease and how to
manage it, and be willing and capable of performing the following study assessments (assessed at Visits 1-5
and just before randomisation):
• patient-led management and adjustment of insulin therapy
• reliable approach to insulin dose adjustment for meals, such as carbohydrate counting
• reliable and regular home-based blood glucose monitoring
• recognise the symptoms of DKA, and reliably monitor for ketones
• implementation of an established “sick day” management regimen
7. Age ≥ 18 years at Visit 1
8. Body Mass Index (BMI) of ≥ 18.5 kg/m2 at Visit 1
9. eGFR ≥ 30 mL/min/1.73 m² as calculated by the CKDEPI formula, based on creatinine measured by the central laboratory at Visit 1
10. Women of child-bearing potential* must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Such methods should be used throughout the study and the patient must agree to periodic pregnancy testing during participation in
the trial. A list of contraceptive methods meeting these criteria will be provided in the patient information
*Women of child-bearing potential are defined as follows:
Any female who has experienced menarche and is not post-menopausal (defined as at least 12 months with no
menses without an alternative medical cause) or who is not permanently sterilised (e.g. tubal occlusion, hysterectomy,
bilateral oophorectomy or bilateral salpingectomy)
11. Compliance with trial medication administration must be between 80% and 120% during the openlabel placebo run-in period for calculation of compliance), to be judged before randomisation

Exclusion criteria:
1. History of T2DM, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
2. Pancreas, pancreatic islet cells or renal transplant recipient
3. T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, glucagon-like-peptide 1 (GLP-1) analogues, SGLT-2
inhibitors, pramlintide, inhaled insulin, premixed
insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1 or any history of clinically relevant hypersensitivity according to Investigator’s judgement
4. Occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1
5. Occurrence of severe DKA (i.e. a pH of Principal Investigator for this trial: Dr Peter Mansell

Research Ethics Committee Reference: 15/EE/0161

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (ARCHIE): a doubleblind randomised placebo controlled trial

Flu (influenza) and flulike illness are among the commonest reasons why parents and carers take children to see a doctor or nurse in winter. Flu is a viral infection, which just causes a mild cough or coldlike sypmtoms in most children. However, when some children get flu, they develop bacterial infections, such as chest or ear infections, which can make them feel even more unwell. `At risk’ children with underlying medical conditions (asthma, diabetes, cancer, cerebral palsy, Down’s syndrome, heart problems, kidney problems , liver problems, or under 2 years of age who were born prematurely) are particularly prone to becoming more unwell from bacterial infections if they get flu. We would like to find out whether giving an antibiotic called coamoxiclav to “at risk” children (between 6 months and 12 years of age) within 5 days of them becoming ill with flu or flulike illness might: 1. Help stop them from developing bacterial infections and becoming more unwell. 2. Help them get better more quickly. 3. Affect how well antibiotics work against similar infections in future. The National Institute for Health Research (NIHR) is funding our research. We hope to recruit participants from general practices, across Thames Valley, Liverpool, Bristol and Southampton regions. In each region we will also aim to include recruitment from at least one outof hours centre and one accident and emergency department. Participant recruitment will be done by a healthcare professional appropriately trained in the study procedures and GCP. They will gain consent for each child to take part in the study from a parent or guardian. The healthcare professional will then record some details about the child’s flulike illness. A nose swab and, if possible, a throat swab will be taken from each child. Each child will be allocated a bottle of study medication, which may contain the antibiotic (coamoxiclav) or a placebo. Parents and guardians will be asked to give children one dose of medication twice a day for five days and to fill in a study diary. Parents and guardians will be asked if they would be willing for their child to have further optional throat swabs after three months, six months and twelve months.

Inclusion criteria:
· Aged 6 months to 12 years inclusive. · In `at risk’ category*. · Presenting with influenzalike illness (i.e. cough and fever**) during influenza season. · Presenting within 5 days of symptom onset. · Permanently registered at a general practice in England. · Parent /guardian able to complete study diary and questionnaires. Notes: *’At risk’ categories: The following `at risk’ categories are intended to guide clinicians in identifying which children are likely to be at greater risk of influenzarelated clinical deterioration or complications. However, healthcare professionals should also use their own clinical judgement to identify `at risk’ children and may discuss children whom they think may be `at risk’ with a medically qualified member of the research team. Respiratory · Asthma requiring continuous or repeated use of controller therapy (e.g. inhaled steroids, leukotriene receptor antagonists, longacting beta agonists, systemic steroids) · Admitted to hospital with exacerbation of asthma within the last 12 months. · Admitted to hospital with bronchiolitis within the last 12 months. · Recurrent viral wheeze (3 or more episodes within the last 12 months). · Bronchopulmonary dysplasia. Cardiac · Congenital heart disease being actively managed or monitored by cardiology team. · Chronic heart failure being actively managed or monitored by cardiology team. Neurological · Chronic neurological or neuromuscular disorder which compromises respiratory function (e.g. cerebral palsy). Renal · Chronic kidney disease defined as either of the following: · Impaired eGFR (estimated glomerular filtration rate) measurement within the last 12 months. · Known hereditary or structural kidney abnormality with or without impairment in eGFR. · Nephrotic syndrome. · Kidney transplantation. Liver · Cirrhosis · Biliary atresia · Chronic hepatitis Immunodeficiency · Asplenia or splenic dysfunction. · HIV infection. · Undergoing chemotherapy leading to immunosuppression. · Taking systemic steroids at a dose equivalent to prednisolone 20mg or more per day (any age) or >=1mg per kg per day (children under 20kg). Other · Diabetes mellitus (type 1 or type 2) or other metabolic condition. · Genetic abnormality (e.g. Down’s syndrome) · Sickle cell disease · Malignancy · Prematurity (born before 37 weeks gestation) in children aged 6 to 23 months. Impaired eGFR is defined as an eGFR measurement of 59 ml/min/1.73m2 or less within the last 12 months before study entry. However, to enter the trial the following two conditions must also be satisfied: 1) eGFR >=30 ml/min/1.73m2 based on most recent measurement within the last 12 months 2) no reason to suspect further deterioration in eGFR at time of study entry. Children with mild or moderate liver disease may enter the trial. Children with severe liver disease may not enter the trial. Severe liver disease is defined as hepatic impairment associated with any of the following: jaundice, impaired coagulation/increased bleeding risk, bilirubin persistently greater than 50 micromol/litre (two measurements within last 12 months). **Fever will be defined as any of the following: childreported fever, parentreported fever or temperature >37.8°C (axillary or tympanic temperature measurement).

Exclusion criteria:
· Known contraindication to coamoxiclav. · Child given antibiotics within the last 72 hours. · Child requires immediate antibiotics or hospital admission (clinician’s judgement). · Presence of any reason to prevent healthcare professional from obtaining high nasal swab. · Child with known cystic fibrosis. · Child previously entered into the ARCHIE study. · Child has been involved in another medicinal trial within the last 90 days.

Principal Investigator for this trial: Dr Louise Wells

Research Ethics Committee Reference: 13/NW/0621

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

R&I Contact Details

Contact information for the Research and Innovation team is detailed below.
Our postal address is:
Research & Innovation
Nottingham University Hospitals NHS Trust
Nottingham Integrated Clinical Research Centre
C Floor, South Block
Queen’s Medical Centre Campus
Derby Road Nottingham NG7 2UH
For general enquiries please email … Continue reading

Genetics of EGFR Mutation (GEM): A translational study of the EORTC lung group

This is a prospective translational research study. The purpose of this study is to identify genetic factors that increase the risk of developing Epidermal Growth Factor Receptor (EGFR) mutant lung cancer and to see whether these factors influence lung cancer outcome. In particular we are looking to identify segments of lung cancer genetic code (DNA) that increases the risk of developing of two specific types of nonsmall cell lung cancer (NSCLC): NSCLC where the tumor has a mutation in a gene called EGFR (usually this is tested routinely in your hospital) ‘EGFR mutant lung cancer’ NSCLC where this mutation in EGFR is not found but patients have never smoked (less than 100 cigarettes in lifetime) or have previously only smoked very lightly (stopped smoking more than 1 year ago and smoked less than 10 packyears). For reasons that are currently unclear, these ‘EGFR mutant’ cancers are more frequently seen in the type of NSCLC called adenocarcinoma. They tend to occur more frequently in women, and are seen more frequently in patients of East Asian (e.g. Chinese) ethnic origin. The reasons why these cancers occur more frequently in these individuals than in the general population are unknown. About 2000 participants will take part in this study. Half of these patients will have NSCLC with a mutation in the EGFR gene, while the other half will have NSCLC without mutations in that gene and at the same time be never smoker (less than 100 cigarettes in lifetime) or exlight smoker (stopped smoking more than 1 year ago and smoked less than 10 packyears). A blood sample will be taken from each participant for analysis. Relevant medical history and demographic information will be collected. Participants will also be asked to complete a lifestyle questionnaire.

Inclusion criteria:
 Histologically or cytologicaly diagnosed NSCLC, all histologies are acceptable. Patients can be included in the study with any disease stage and at any time during the disease course. Any type (surgery, RT, chemotherapy, targeted agents) of previous treatment and any line of treatment are eligible. Age 18 years. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol those conditions should be discussed with the patient before registration in the trial Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Case Cohort: Patients with proven EGFR mutation in exons 1821 from tumor material (either primary tumor or metastasis). No known somatic KRAS, HER2, LKB1, BRAF, or PI3K, mutation or ALK gene rearrangement (or ALK3+ immunohistochemistry). If these mutations are known to be present the patient will be ineligible. However, patients will not be tested specifically for these mutations for this study and patients with unknown status are acceptable. If patients are subsequently tested after enrollment and found to harbor any of these mutations they will be considered ineligible and will be replaced. No known Li Fraumeni, Li Fraumenilike, or Peutz Jeghers syndrome family, or known germline carriers of mutant LKB1 or TP53. Patients will not have to be tested specifically for these syndromes to be eligible for this study. Control Cohort: Patients known to be somatic EGFR “wildtype,” i.e. no mutation detected in exons 1821 from tumor material. Never smoker (Exclusion criteria:
 Patients with unknown or failed tumor EGFR genotyping will be ineligible. Patients subsequently undergoing re genotyping which demonstrates an EGFR mutation will become eligible for the “case” cohort. Patients subsequently undergoing regenotyping which demonstrates an EGFR wildtype will become eligible for the “control” cohort.

Principal Investigator for this trial: Dr Ivo Hennig

Research Ethics Committee Reference: 14/YH/0062

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

Adjuvant peginterferonalpha-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomised phase III trial of the EORTC Melanoma Group.

Patients with stage II primary melanoma generally have a good prognosis after resection. However, once melanoma metastasizes beyond regional lymphnodes, the median survival is approximately 7 months. Ulceration is defined as the absence of intact skin covering a major portion of the primary melanoma based on microscopic examination. Survival rates of patients with an ulcerated melanoma are proportionally lower than those of patients with equivalent categorisation, but nonulcerated, melanoma. In patients with localized melanoma, tumour thickness, mitotic rate and ulceration are the most dominant prognostic factors. Interferon (IFN) alfa 2b is the most investigated agent for adjuvant treatment of patients with melanoma that are high risk of recurrence after definitive surgery. It has demonstrated consistent effects on overall survival (OS) compared with observation alone, and demonstrated low and intermediatedose regimens are more tolerable for longer periods of time it has produced transient improvements in recurrencefree survival or distant metastasesfree survival. However, no trial has indicated the optimum dose and duration for adjuvant interferon alfa in these highrisk melanoma patients. One EORTC trial suggested that longer duration of treatment with lower doses may be more effective than shorterterm therapy at higher doses. In previous EORTC trials, patients with ulcerated primaries have a greater benefit from IFN than nonulcerated primaries. This indicates that IFNadjuvant therapy might be sufficiently effective in ulcerated melanoma to become standard care. This means that after almost 20 years of IFN trials we might identify the patient subpopulation that significantly benefits not only at the recurrencefree survival level but also at the OS level. The consistency of these observations is striking and justifies a Randomized Clinical Trial to address the question of efficacy, toxicity and quality of life with peginterferon alfa2b as compared to observation after adequate surgery for ulcerated primary cutaneous melanomas.

Inclusion criteria:
 Subjects must have histologically documented ulcerated primary cutaneous melanoma with a Breslow thickness > 1mm that has been excised radically 3 months prior to randomization. Excision margins of at least 1 cm are required. In the head and neck areas and in case of locations distally on extremities narrower margins are acceptable as long as they are radical. In case subjects have undergone Sentinel Node staging after the excision of the primary, this must be done within the time frame of 3 months between the date of final excision of the primary and the date of randomization. Subjects must have an ECOG performance status of 0 or 1. Subjects must be between 1870 years old. Subjects must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 4 weeks prior to initiation of study treatment Subject must give informed consent according to ICHGCP or national/local policy

Exclusion criteria:
 Subjects suffering from a mucous membrane melanoma or ocular melanoma Subjects who have evidence of (non)regional lymph node metastases or intransit metastases (even if they have been resected) Subjects whose disease cannot be completely surgically resected Subjects who have not recovered from the effects of recent surgery Subjects with a history of prior malignancy within the past 10 years other than surgically cured nonmelanoma skin cancer or cervical carcinoma in situ Subjects who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease Subjects with thyroid dysfunction not responsive to therapy Subjects with uncontrolled diabetes mellitus Subjects suffering from an active autoimmune disease Subjects with active and/or uncontrolled infection, including active hepatitis Subjects who have a history of seropositivity for HIV Subjects who have a history of neuropsychiatric disorder requiring hospitalization Subjects who are known to be actively abusing alcohol or drugs Subjects who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception Subjects with a medical condition requiring chronic systemic corticosteroids Subjects who have received any experimental therapy within 30 days prior to randomization in this study Subjects who have received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma Subjects who have previously received interferonalpha for any reason Subject having history of epilepsy or other major central nervous system disease Subject having eyes disorders

Principal Investigator for this trial: Professor Poulam Patel

Research Ethics Committee Reference: 13/YH/0159

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

Standards, Procedures and Guidance

Our current standard operating procedures, regulatory standards, guidance documents, templates and forms are regularly updated please ensure that you are using the most current version.
If you need further assistance then please contact our QA/GCP Auditor Melanie Boulter.

Vacancy: Senior Research Manager (Regulatory Compliance & Award Management)

NUH Research & Innovation has a vacancy for a Senior Research Manager to lead on Regulatory Compliance & Award management.

Forthcoming MHRA inspection at Nottingham University Hospitals NHS Trust

The MHRA GCP Inspectorate is due to inspect NUH. The Trust was notified in February 2013 that an inspection is due to take place but as yet, the date and agenda of the inspection has not been confirmed. Continue reading

New Clinical Trials Toolkit uses tube map concept to guide researchers

NIHR has launched a new Clinical Trials Toolkit which is based on the design of a tube map. The clickable diagram differentiates between legal and good practice requirements, providing essential information at the ‘stations’ along the route

A phase III randomised study of preoperative radiotherapy plus surgery versus surgery alone for patients with Retroperitoneal sarcoma (RPS).

The long term outcome for patient with retroperitoneal sarcomas is poor. The major event leading to the poor outcome is local recurrence in the abdomen. The main objective of this study is to assess whether preoperative radiotherapy, as an adjunct to curativeintent surgery, improves the prognosis of patients with retroperitoneal sarcoma. This is a phase III multicentre randomised study to assess whether there is a difference in abdominal recurrencefree survival between retroperitoneal sarcoma patients undergoing curativeintent surgery alone and those undergoing preoperative radiotherapy followed by curativeintent surgery. It will further assess whether there is a difference in metastasisfree survival, abdominal recurrencefree interval and overall survival between patients undergoing curativeintent surgery alone and those undergoing preoperative radiotherapy followed by curative intent surgery. It will also assess the tumour response in patients undergoing preoperative radiotherapy and the toxicity of preoperative radiotherapy given prior to curative intent surgery in patients with retroperitoneal sarcoma. Patients older than 18 years, with an operable primary unifocal soft tissue sarcoma of retroperitoneal space or infraperitoneal spaces of pelvis will be eligible for this study. The study will be conducted at 8 major sarcoma centers across the UK and in several European countries. Over 39 months, 256 patients will be entered into the trial. Half of the patients will undergo preoperative radiotherapy followed by standard curativeintent surgery, while the other half of the patients will undergo standard curativeintent surgery alone. After completion of the study treatment, patients will be seen regularly at the treatment hospital for clinical examination and scans in order to assess of side effects and the status of the disease.

Inclusion criteria:
Tumourrelated criteria: Primary soft tissue sarcoma of retroperitoneal space or infraperitoneal spaces of pelvis Sarcoma not originated from bone structure, abdominal or gynecological viscera Unifocal tumor (not multifocal disease) Absence of extension through the sciatic notch or across the diaphragm Histologicallyproven RPS (local pathologist/ imagingguided or surgical biopsy), excluding the following histological subtypes: Gastrointestinal stromal tumor (GIST) Rhabdomyosarcomas PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma aggressive fibromatosis sarcomatoid or metastatic carcinoma  Tumour not previously treated (no previous surgery excluding diagnosis biopsy, radiotherapy or systemic therapy) Tumour both operable and suitable for radiotherapy (This will be based on pretreatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist and radiologist (anticipated macroscopically complete resection, R0/R1 resection) Patients for whom surgery is expected to be R2 on the CTscan before randomization are not eligible Patients must have American Society of Anesthesiologist (ASA) score 2 (see Appendix G) The criteria for nonresectability are: (i) involvement of superior mesenteric artery or (ii) involvement of aorta or (iii) involvement of bone No metastatic disease Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by abdominopelvic CT (IV and PO contrast) or MRI (with IV contrast) within the 28 days prior to randomization Patientrelated criteria: 18 years old WHO performance status 2 (see Appendix C) Absence of history of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease Normal renal function: Calculated creatinine clearance within normal value (calculated by CockcroftGault see Appendix E) Functional contralateral kidney to the side involved by the RPS as assessed by intravenous pyelogram (done during the baseline CTscan) or differential renal isotope scan Normal bone marrow and hepatic function: White Blood cells 2.5 x10 9 cells/L Platelets 80 x10 9 cells/L Total bilirubin Principal Investigator for this trial: Dr Claire Esler

Research Ethics Committee Reference: 11/LO/2024

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

HEAT (Helicobacter Eradication Aspirin Trial): Can eradication prevent ulcer bleeding?

In 2007 there were 12,864 hospital admissions in England for gastric duodenal or peptic ulcer haemorrhage. HEAT is a large scale outcomes study designed to see whether a one week course of H. pylori eradication reduces hospitalisation for ulcer bleeding in patients using aspirin. With funding from the NIHR HTA Programme, it is being led by the University of Nottingham, with recruiting centres across the UK. Continue reading

Nottingham Penthrox acute pain control trial opens the door to research in A&E

Support provided by the Comprehensive Clinical Research Network recently helped NUH overcome the challenges of A&E and become the top recruiting site in an acute pain study. NUH demonstrates how to successfully conduct a clinical trial in a difficult Emergency Department environment. Continue reading

Nottingham University Hospitals R&I Research Manager vacancy, applications close 17th February

Do you wish to make a difference to research in the NHS? An opportunity has arisen for a Research Manager to join the Research & Innovation Department at Nottingham University Hospitals (NUH) NHS Trust. As Research Manager you will be a key member of the NUH R&I department and will play an important role in supporting the implementation of the Trust’s Research Strategy. Continue reading


Introduction to Good Clinical Practice (GCP) Training Course
NIHR deliver regular GCP training.
For further information on GCP Training please visit the NIHR Website.
HRA Training
NUH R&I are currently delivering training on the HRA approval process and the changes to the research process. … Continue reading

R&I Team Profiles

Dr Steve Ryder
Director of Research
Since June 1994 Dr Ryder has been a consultant Physician in Hepatology and Gastroenterology at the Nottingham Digestive Diseases Centre and Biomedical Research Unit. His major clinical and research interest is hepatitis C infection.
Dr Ryder … Continue reading

Entries Open for Clinical Research Site of the Year 2011

The PharmaTimes has opened a new competition, the Clinical Research Site of the Year, which is jointly sponsored by the NIHR and the ABPI. A new category of the Clinical Researcher of the Year competition, it has been introduced in recognition of the importance to the UK’s global competitiveness that a clinical research site can make. Continue reading

Regulatory Standards

Below is a selection of links related to regulatory standards which are relevant to Healthcare research in the UK. If you cannot find what you are looking for then please contact us on 0115 9709049.


Research Governance Framework, 2nd ed

Legislation & … Continue reading

Life Sciences Industry

Commercial research is important to NUH as the driving force for the adoption and diffusion of innovation.

It is through this process that new treatments, devices or laboratory tests are studied and brought forward for use by patients and staff.
Nottingham … Continue reading

NUH R&D completes MHRA inspection successfully

The MHRA has completed a four day routine GCP inspection of systems and processes. This took place in the last week of February and we were notified at the close of the audit that there were no critical findings. A … Continue reading

NUH routine MHRA inspection in February

NUH will soon undergo a routine GCP systems inspection by the MHRA (Medicines and Healthcare Products Regulatory Agency). This will take place during the last week of February and is coordinated by the R&D
department. The investigators who will be … Continue reading

This site uses cookies. Find out more about this site’s cookies.