Persephone Newsletter Issue 19 Duration of Trastuzumab with Chemotherapy in Women with Early Stage April 2012 Breast Cancer: Six Months Versus Twelve
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Persephone Newsletter Issue 19 Duration of Trastuzumab with chemotherapy in women with early stage April 2012 breast cancer: Six months versus Twelve Top 50 recruiters (as of 18.04.12) Addenbrooke's Hospital 54 Peterborough City Hospital 47 Norfolk & Norwich University Hospital 41 Royal Liverpool University Hospital 41 New Cross Hospital 41 Southend Hospital 39 Maidstone Hospital 36 Southampton General Hospital 36 James Paget Hospital, th The Royal Derby 36 Norfolk recruited the 2000 Luton and Dunstable Hospital 34 th patient on 12 April 2012. Well Royal Sussex County Hospital 33 done, congratulations and thank St Bartholomew's Hospital 31 you to Dr Adrian Harnett who Queen's Hospital (Romford) 30 Wexham Park Hospital 30 consented the patient and Adele Eastbourne District General Hospital 29 Cooper who randomised the Christie Hospital 27 patient into the trial. A gift of our Cumberland Infirmary 26 thanks and appreciation will be Diana Princess of Wales Hospital 25 on its way to you and the team. Bedford General Hospital 25 Cheltenham General Hospital 24 Queen's Hospital (Burton) 24 We are halfway there!!! Royal Hampshire County Hospital 24 2000/4000 patients recruited. Russells Hall Hospital 23 A big thank you and well done Princess Royal University Hospital 23 to all sites that have recruited Macclesfield District General Hospital 23 into Persephone…... Manor Hospital 23 Sunderland Royal Hospital 22 every patient matters. University Hospital Of North Durham 22 Great Western Hospital 22 Latest recruitment news Torbay Hospital 22 2012 has kick-started with some fantastic recruiting months: January and Queen Elizabeth Hospital (Birmingham) 21 March both recruited 76 patients each which is above the monthly target of University Hospital Of North Tees 21 St. Mary's Hospital (London) 21 70 patients. Recruitment has really picked up and these months are our Royal Gwent Hospital 21 second highest accrual months so far. Current accrual stands at 2021 Raigmore Hospital 21 patients. Other important announcements: Staffordshire General Hospital 21 The trial has met a major milestone, we have now reached Mount Vernon Hospital 21 50% of the recruitment target. Keep up the good work and University Hospital 21 help us reach the next milestone of 3000 patients by end of Queen Elizabeth Hospital (London) 20 March 2013. St. George's Hospital 20 The first quarter of 2012 has set the recruitment record for Barnet Hospital 20 consistently high recruiting months so please continue to screen and Warrington Hospital 20 recruit more patients into Persephone to help boost this record further! Royal Shrewsbury Hospital 19 William Harvey Hospital 19 A total of 147 sites are now open with only a few more in set-up. James Paget Hospital 19 The most recent sites to open include Rotherham Hospital, Wansbeck Essex County Hospital 19 General Hospital and Solihull Hospital. Queen Elizabeth Hospital (Gateshead) 18 The most recent new sites to recruit their very first patient include Guy's Hospital 18 Solihull, Western General, East Surrey, Royal United Bath, Wansbeck Stoke Mandeville Hospital 17 General, Weston Park and King’s Mill Hospital. Thank you to all!! Royal Surrey County Hospital 17 3000 PERSEPHONE ACCRUAL AGAINST TARGET 2500 Cumulative Recruitment 2000 Predictive accrual revised in 1986 October09 18491910 17231773 1500 16061670 14751516 13411405 12311292 1000 10991157 984 1020 873 924 773 811 500 676 718 586 629 492 539 Numberofpatients randomised 116 136 161 182 203 235 273 303 329 372 417 446 0 Congratulations also go out to…. LVEF data collection Please remember LVEF assessments must be carried out by ECHO or MUGA at baseline (prior to starting Essex Congratulations and thank you to RN County Trastuzumab) and at every 3 months for all patients Louise Chapman for randomising the Hospital, th randomised into Persephone. LVEFs must be documented 1999 patient and to Dr Philip on page 2 of the Trastuzumab Treatment form under the Colchester Murray for consenting this patient. recruited section ‘Cardiology Assessment details’ in the following th order: 1999 patient Trastuzumab cycles 1-4 and baseline LVEF details Trastuzumab cycles 5-8 and 3 month LVEF details Trastuzumab cycles 9-12 and 6 month LVEF details A thank you gift will be on its Trastuzumab cycles 13-16 and 9 month LVEF way to both Sites details Trastuzumab cycles 17 & 18 and 12 month LVEF details Congratulations and thank Repeat LVEFs to check whether abnormal LVEF Western General you to RN Elaine Murray assessments have returned to normal must be carried out Hospital, Edinburgh for randomising the 2001st in all cases where there is: recruited patient and to Dr Angela An absolute reduction of less than 10% and the 2001st patient Bowman for consenting LVEF is ≥6% below the Sites lower limit of normal this patient. An absolute reduction of 10-15% and the LVEF is below the Sites lower limit of normal by 1% or more Data return All repeat LVEFs must also be documented on the Thank you for returning the CRFs requested in Januray Trastuzumab Treatment form. 2012. We are working hard to achieve 100% data return. ISF checklist and Pharmacy checklist Hence, another round of requests for expected and outstanding data is due to be sent to all Sites week If you have not already done so please return your commencing 23rd April 2012. Please complete and return completed and signed ISF and Pharmacy checklist to the all CRFs outstanding for your patients prior to the deadline Persephone Trial Office on fax 0247 615 1586. specified. It is vital that all completed checklists are returned as If your patient has transferred hospital please remember to soon as possible as these form a means of remote complete the Hospital Transfer form in order that we may monitoring to check that all Sites are using the correct and continue ongoing follow-up at the new hospital. most up to date versions of the Persephone trial documents. PERSEPHONE team (For efficiency please address your query to the relevant team member) General Enquiries & Data Management Emma Ogburn [email protected] Trial Co-ordinator (Warwick) Phone: 0247 615 0492 Shrushma Loi (Wed-Fri) [email protected] Trial Coordinator (Warwick) Phone: 0247 615 0492 Trial supplies (site files) Donna Howe [email protected] Outstanding set-up documents Clinical Trial Administrator (Warwick) Phone: 0247 615 0600 Trial supplies (CRFs etc) Matthew Dalby [email protected] Data Queries Date Input Clerk Phone: 0247 615 1127 Data Input Sharisse Alleyne [email protected] Date Input Clerk Phone: 0247 615 1786 Pharmacovigilance, Pharmacy & Translational Louise Grybowicz – Blood Collection [email protected] Studies (Cambridge) Phone: 01223 348447 Kevin Baker - Block Collection [email protected] (Cambridge) Phone: 01223 348083 Site initiations Caroline Jevons (Tue & Weds) [email protected] Recruitment Facilitator (Warwick) Phone: 0247 615 0990 The views and opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health .