News
2010
July 2010
EnROL
We are pleased to announce that the EnROL Trial is now open to recruitment at Leighton Hospital
June 2010
EnROL
We are pleased to announce that Queen Alexandra Hospital, Portsmouth, is now open to recruit patients into the EnROL Trial.
QUASAR 2
QUASAR 2- Stage II patient randomisation closed.
May 2010
QUASAR 2
QUASAR 2 – 1892 Patients Recruited! Stage II Recruitment Completed I am excited to announce that QUASAR 2 has now recruited the 1892 stage II and stage III patients required to answer our primary study objective of 3 year disease free survival in all patients. As you are already aware, we are now switching to stage III patient randomisation only and will continue to recruit until we have accrued 1411 stage III patients. Any stage II patients that have already been offered the trial may still be randomised until end Friday 11th June. After that point the QUASAR 2 randomisation database will no longer process these patients. Rachel Midgley
AspECT
PPIs and Clopidogrel - update
MHRA have recently updated their safety advice regarding the concomitant use of Esomeprazole and Clopidogrel. The published advice is available here: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON076501
The MHRA advise that concomitant use of Clopidogrel and omeprazole or Esomeprazole is to be discouraged unless considered essential. AspECT Principal Investigators should carefully consider this information. Because it is not possible to completely exclude a possible interaction with Esomeprazole on the basis of available data, the potential risk of a slight reduction in efficacy of Clopidogrel should be weighed against the potential gastrointestinal benefit of the PPI. The TMG will consider possible further recommendations for AspECT patients at the next meeting to be held on 24Jun2010 and will provide further guidance after that date.
April 2010
QUASAR 2
Recruitment Update - 12th April 2010
Just a quick message to clarify the situation regarding QUASAR 2 recruitment. Yes, we are still randomising stage II patients into the trial; the end of March 2010 was our (optimistic!) target for recruiting 1892 all-stage patients, but we still have 44 patients to go! Please do not feel that you can no longer consider these patients for QUASAR 2, and treat this as your last opportunity to offer this group of patients the trial.
You will be informed by the Trial Office when we have accrued 1892 patients and at this point please stop offering the trial to stage II patients, as we will then move to stage III randomisation only. However, please note that stage II patients that have already been offered the trial at this point may still be randomised.
Best wishes, Rachel Midgley
2009
November 2009
DATACAP Trial Opens
We are delighted to announce that the DATACAP trial has opened to recruitment at the Churchill Hospital, Oxford. The plan is to recruit 32 patients at this single site. We would like to thank all involved for their efforts so far.
Rachel Midgley and David Kerr
Click here for further details about the trial.
FOXFIRE Trial Opens
We are delighted to announce that FOXFIRE is now open to recruitment! Congratulations to Royal Surrey County Hospital for being the first site activated! We hope to open more sites very soon and would like to thank all involved for their efforts so far.
Rachel Midgley and David Kerr
Click here for further details about the trial.
QUASAR 2
Recruitment news
STOP PRESS! QUASAR 2 LAST PUSH. TOTAL 1900 PATIENTS REQUIRED. ANTICIPATED CLOSE DATE END MARCH 2010!
Firstly a HUGE thank you for recruiting to this study over the last few years - it has been a long journey but one that we have enjoyed and we hope you have too! I think we all concede a certain disappointment in the results of C-08 presented at ASCO this year. However the results were tantalising and C-08 was different to QUASAR2: We remain the only study in the world to be testing Avastin in combination with single agent chemotherapy in the adjuvant setting of colorectal cancer. So QUASAR2 trial is of resounding importance in determining the role of anti-angiogenic therapy in this setting.
Because of the slightly slower, and therefore more prolonged, recruitment of QUASAR2 (and therefore increased chance of an event) fewer patients will be required to achieve the primary and secondary endpoints. Our statisticians have confirmed that we require a total of 1900 all-stage patients to achieve the primary endpoint of 3-year disease-free survival benefit in the overall population, with 90% power.
These numbers (about 200 in total to go) are expected to be achieved by the end of March 2010 if we recruit 50 patients per month. Can you help us do this? We think you can. Let's do it even faster. Let's get 1 patient per site per month and have it completed for Christmas!
Rachel Midgley and David Kerr
QUASAR 2
Further to the recent press release from Roche (see attached) re: the preliminary results of the C-08 trial of Avastin in the adjuvant treatment of colon cancer, we would like to confirm to our research community that we do not feel these results impact upon the continuing validity of or rationale for the QUASAR2 study. Indeed we believe that this result re-emphasises the importance of the QUASAR2 study. At the present time the results from the C-08 trial have not been released and are due to be presented at the ASCO meeting next month. However the trial tested the benefit of Avastin when added to a 5FU/oxaliplatin regime, which is significantly different to the question being asked in the QUASAR2 study, where we are assessing the effect of Avastin when added to single agent capecitabine. We are pleased to report that recruitment into QUASAR2 is going very well with today’s recruitment figure standing at 1459 of a required total of 2240. We thank you wholeheartedly for your continuing support.
Rachel Midgley and David Kerr
October 2009
Recruitment News COG now has 25 sites open to recruit patients however we still require more sites so please contact us if you’re interested in setting up this exciting trial at your site. We will also be applying for the trial to be extended by an extra year.COG
July 2009
AspECT
PPIs and Hip Fracture
Weighing up the evidence for risks and benefits of drug presciption is always difficult. Please click below for an American Journal of Gastroenterology paper by Paul Moayyedi about PPIs and hip fracture.
Click here to see full article.
June 2009
SCOT
Decision regarding the 2 randomisation time points:
"At the TSC meeting on 16th June 2009, the independent members of the committee came to a decision in relation to the 2 randomisation time points, based on the data presented in the first interim analysis report. The decision made was that the study should continue with the upfront randomisation time point only, for the rest of the duration of the study. This will be implemented on Monday 6th July 2009. Form this point onwards, all patients entered on to the study will be randomised upfront to either 12 or 24 weeks of treatment. This change will not affect sites currently randomising their patients upfront. All SCOT sites currently open to recruitment will be emailed as soon as possible with further details.
**Please also note that patients already registered to the study from sites currently on the delayed randomisation time point, these patients will still require to be randomised at week 12.**"
AspECT
PPIs and Clopidogrel
Moayyedi and Sadowski have published an editorial about PPIs and Clopidogrel. You can download a PDF of the journal article here.
Please go to the AspECT restricted section for more guidelines and information relating to the management of AspECT patients.
EnROL
We are delighted to announce that University Hospital of North Tees has been activated to recruit patients into EnROL.
May 2009
Cancer Research UK have published a press release (29Apr2009) titled "Aspirin for forty somethings could cut cancer risk". This suggests that taking aspirin in your 40s could cut the risk of cancer developing later in life.
Click here to see full article
SCOT
The number of CT scans mandated by the protocol is currently under review.
Click here for further details about the trial.
April 2009
EnROL
The EnROL Investigators Meeting will be held on the 1st July 2009 at the Goodenough College in London. All site staff involved with the trial are invited to attend this meeting.
March 2009
AspECT
AspECT recruitment phase is now closed having met and exceeded the recruitment target. Final number recruited is 2513 with a record 145 patients recruited during February.
February 2009
EnROL
We are pleased that University Hospital of North Tees has agreed to participate in the EnROL trial and is now in set up. We would like to welcome Mr Talvinder Gill and Alison Chilvers on board.
January 2009
AspECT
The AspECT recruitment period has been extended to 27 February 2009. There are only 138 patients left to recruit to reach our target of 2500.
2008
November 2008
AspECT
AspECT is drawing to the end of its recruitment phase. In this last push to get the total recruitment to 2500, we need each site to recruit just 4 patients - i.e. 2 per month. This is easily achievable.
Please note that for drug resupply over Christmas and New Year, all orders must be placed by 19th Dec 2008 (17th Dec 208 for Northern Ireland). Normal service will resume on 05 Jan 2009.
Please do not send any samples from Friday 19 December 2008 until Friday 02 January 2009.
October 2008
AspECT at the DSMC
The DSMC met on 26th September 2008 and were optimistic about recruitment and could see no reason from a data and safety viewpoint for the trial not to continue.
EnROL Recruitment
EnROL has now 3 active sites and 3 patients recruited.
COG
COG has received MHRA -CTA Approval and a Provisional Favourable Ethics Opinion, awaiting Final Approval. Site set-up is in progress.
SCOT
We have been requested by the Sponsor of the study to highlight to all recruiting sites a recent protocol violation concerning the dose of capecitabine given to patients over the age of 70. The protocol states 'Patients >/= 70 years and or patients < 70 years with a creatinine clearance 30-50 mls/min will commence treatment with capecitabine at 75% of the full dose.' Please ensure this is checked and adhered to for all patients you are currently treating or will be treating in the future.
September 2008
VICTOR at ESMO 2008
A presentation looking at recurrence rates in VICTOR patients according to COX-2 genotyping has been accepted for presentation at this year's ESMO conference in Stockholm (12-16 Sept 2008).
Click here to view the poster
– PDF-File, 60.6 KB
February 2008
QUASAR 2 breaks all-time monthly recruitment record in January 2008!
January 2008 saw what we hope will be the start of good things to come. 70 patients were randomised into the study besting our previous record of 51. A big ‘thank you’ goes out to everyone for their efforts.
We have now randomised over a third of our total patient target and we hope that this success can continue as we move into our last full year of recruitment.
OCTO's New Address - effective from 18th January 2008
Oncology Clinical Trials Office (OCTO)Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
off Roosevelt Drive
Headington
Oxford
OX3 7DQ
Tel: +44 (0) 1865 617000
Fax: +44(0) 1865 617010
2007
13th November 2007
Application of mobile phone technology for managing chemotherapy-associated side-effects
There were 91 alerts—54 red and 37 amber; 54% (29/54) of the red alerts were data delay and transmission problems which were swiftly rectified. The remaining red alerts were managed appropriately by the study nurses. Both patients and staff felt confident in this approach to symptom management.
The patients felt secure in the knowledge that their symptoms were being closely monitored and that they were participating effectively in their own care management.
Click here to see the full article
30th August 2007
AspECT
The FDA communication on omeprazole and esomeprazoleFollowing their report to the FDA, AstraZeneca has provided data to two members of the AspECT trial management group (TMG) on the association between the use of omeprazole or esomeprazole and cardiac events. Concern was generated when one European randomized trial comparing omeprazole with surgery for gastro-esophageal reflux appeared to show a greater number of patients with cardiac events in those treated with omeprazole during a maximum of 14 years follow-up. The excess events seemed to occur within the first 2-3 years. A retrospective analysis of 12 randomized controlled trials of omeprazole compared to placebo revealed no trend towards increased cardiac events in those treated with omeprazole over 6-24 months follow-up. Another randomized trial comparing esomeprazole with laparoscopic surgery for gastro-esophageal reflux disease did not find any difference in the number of cardiac events between the two groups and this was also the finding of 10 placebo controlled randomized controlled trials of esomeprazole with at least 6 months follow-up.
It is the conclusion of the AspECT TMG that the body of evidence shows no association between omeprazole or esomeprazole and risk of cardiac events. There were a number of methodological problems that threaten the validity of the trials as the studies were not designed to address cardiovascular end points. Furthermore given the number of negative studies, the apparent increase in cardiac events seen in one trial was probably a chance finding. The continued evaluation of the safety of all drugs is important but when a large number of secondary analyses are done in search of potential harms, then apparent numerical differences will occasionally be seen by chance. The TMG believe this is an example of such a chance finding but will continue to review further data as they become available.
Click here for the full FDA statement
26th July 2007
VICTOR
Rofecoxib and Cardiovascular Adverse Events in Adjuvant Treatment of Colorectal Cancer N Engl J Med 357;4 July 26, 2007 It is too early to comment on the benefit of Vioxx® [rofecoxib] in preventing recurrences from colorectal cancer. The VICTOR study (Vioxx In Colorectal cancer Therapy: definition of Optimal Regime) confirms that the two-fold increase in risk of adverse cardiovascular events reported in Vioxx® clinical trials applies in patients with colorectal cancer. Our results have implications when selecting patients for treatment with Cox-2 inhibitors, but it has to be remembered that improved treatment for colorectal cancer is badly needed. By far the commonest cause of death to be expected in these patients in the decade following cancer treatment is from recurrence of their cancers, and not from cardiovascular disease.
Examination of risks of cardiovascular events at different periods during the trial is impeded because the overall numbers of patients with such events were low relative to the total numbers of patients treated. Also, because the trial was stopped prematurely there were too few patients completing full treatment courses to allow confident conclusions about risks late in treatment.
Statement by Professors David Kerr (University of Oxford) and Michael Langman (University of Warwick)
Click here for full article
