1 Patients was recruited into the CHOP-OR Trial in September bringing the total number of patients to 33.
The SCOT trial is moving in to the final two months of recruitment, due to end recruitment at the end of November 2013. As of the 3rd Oct 2013 total trial recruitment is 5880 – thanks to sites for the excellent recruitment so far! Please keep up the good work to the end of recruitment period in order to maximise the power of the study - and the huge effort contributed by sites throughout the study duration.
2 Patients were recruited into the CHOP-OR Trial in August bringing the total number of patients to 32.
We are delighted to have received favourable ethical opinion for LINES, a euroSARC Trial of Linsitinib in advanced Ewing Sarcoma.
The translational aspect of the SCOT study, TransSCOT, with the aim to collect up to 5000 matched blood and tissue samples, was launched at the end of 2012. Tissue and blood collection packs have been sent to all UK sites; sample return has been very is good to date, at the start of Aug2013 1110 blood samples and 1035 pathology samples returned – approximately 27% of expected samples. Denmark is keen to contribute to transSCOT and processes to initiate collection are in progress. OCTO and Oxford Labs co-ordinate the blood sample collection, Glasgow CTU and the Glasgow bio-bank co-ordinate the collection of pathology samples. Recruitment progresses steadily - 5710 as of 01Sep2013. All sites are thanked for their support and encouraged to maintain the momentum to ensure recruitment target is reached.
A reminder that the 6MP trial is actively recruiting and needs to reach a total of 65 patients. Currently 44 patients are registered (August 2013). Click here for more details of inclusion/exclusion criteria and participating sites:
Please also find a 6MP Sites Location Map here:
The next AspECT datalock is on 28th August 2013 so please send in any completed CRFs to arrive at OCTO as soon as possible. All 4 year follow ups should have been completed by now.
3 Patients were recruited into the CHOP-OR Trial in July bringing the total number of patients to 30.
We have recently made a substantial and exciting change to the PACMEL trial in order to include a third drug for testing and a third randomisation arm. This will evaluate the efficacy and safety of paclitaxel with pazopanib, in addition to the established paclitaxel with GSK1120212 (trametinib) and paclitaxel alone arms. A non-randomised phase II trial of pazopanib with paclitaxel has shown promising results for the combination in this patient group, so comparison of pazopanib with the paclitaxel-only arm of the PACMEL trial is an important research question. Ethics and MHRA approval for the amendment has been received and implementation of the amendment at participating sites is ongoing. An additional 40 patients will be randomised to recruit the third arm and recruitment has been extended to December 2014.
STAGE ONE EFFICACY ANALYSIS COMPLETE - SUFFICIENT EFFICACY OBSERVED. RECRUITMENT TO CONTINUE TO 65.
6MP uses a Simon two-stage minimax design. In stage one, 30 patients were evaluated. If fewer than 3 out of the first 30 evaluable patients had shown a response after 8 weeks, the trial would have been stopped for futility. The Trial Management Group recently met to discuss the results from the first efficacy analysis, and concluded that the trial will continue to the next recruitment target of 65 patients, because more than 3 patients from stage one had shown a response to the trial intervention (the definition of response includes complete response, partial response and stable disease as measured by RECIST V1.1. This is CTAAC approved.)
ASCO ACCEPTANCE (31st May - 4th June 2013)
We are delighted that 6MP was accepted and presented a "trials in Progress" Poster presentation at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. click here to see the poster.
There are two planned data locks this year, on 8th April and 28th August. When we do a data lock we freeze the data a point in time, and produce tabulations which we use to identify outliers, inconsistencies, and missing treatment or outcome data. We also look for things like missing final Follow Up CRFs for patients reported as deceased on an SAE or End of Treatment CRF . the DSMC expect their next annual report to show that ALL follow up and endoscopy data is complete for all patients up to and including the 4 year timepoint. Requests for outstanding trial data are sent every three months but please, in particular, try to catch up to the 5 year time point for all patients. To be included in the next data lock we need to have received your CRFs by 14th August 2013.
Current recruitment 2 Patients (June 2013)
The recruitment period has been extended to March 2014 to enable recruitment of 35 evaluable patients. Please continue to screen for eligible patients.
Another 2 patients were recruited in May 2013 taking the current total to 27.
The COG trial results have now been presented at both ESMO and the NCRI meeting and PRO results have been presented at the ASCO GI meeting. All presentations were very well received by the medical community and now a paper has been submitted to the New England Journal of Medicine. We will notify site staff once we hear if the paper has been accepted by the journal. 45 out of the 48 recruiting sites have been closed out and we are very grateful for all the hard work site staff have put into preparing COG documentation for archiving.
Regulatory approval was recently received for a substantial amendment to introduce intermittent dose schedules for the experimental drug AZD8931, in combination with XELOX . Patients are currently being screened and recruited to the new protocol for the dose escalation phase in order to establish the maximum tolerated dose of the combination.
We are pleased to report that the DOC-MEK trial results have been presented at ASCO (01 June 2013 - click here to see the poster) and the Society for Melanoma Research (11 Nov 2012). the publication has been prepared and submitted to peer-reviewed journal. OCTO have also submitted an abstract describing trial management of this Investigator-Sponsored NCRN-AstraZeneca alliance trial to NCRI in November 2013.
We are currently completing the analysis and writing up the results of the EnROL Trial. We hope to have a paper submitted during summer 2013. The results are also being presented at the following conferences:
We are preparing an application to CTAAC for funding for long term follow up of all patients. More details to follow in the summer.
Recruitment is being extended until June 2014. At the end of May 2013, we had recruited 209 patients and are over half way to our recruitment target of 320. to drive recruitment we are in the process of opening six more sites which include:
These Chemotherapy-only sites will feed into the two high performing radioembolisation sites at Leeds and Cambridge.
The dose escalation phase of the PACMEL Trial has now been completed and the randomisation phase has been opened to recruitment. We are currently in the process of opening 12 new sites for recruitment in to the randomisation phase, of which 6 have been opened (9 sites in total).
Recruitment to the safety cohort has recently been completed and we have moved to the randomised trial of whole brain radiotherapy with vandetanib or placebo. Five sites are currently active across th eUK and an additional five sites are currently being set up.
The translational aspect of the SCOT study, TransSCOT, with the aim to collect up to 5000 matched blood and tissue samples, was launched at the end of 2012. Tissue and blood collection packs have been sent to all UK sites and there has been an excellent return response from sites to date. OCTO and Oxford Labs co-ordinate the blood sample collection, Glasgow CTU and the Glasgow bio-bank co-ordinate the collection of pathology samples.
Cancer Research UK Press Release 17 August 2012: Trial launch of urgently needed combination treatment for oesophago-gastric cancer
Data cleaning is in progress prior to our analysis data lock on the 20th August.
A welcome to Sweden who have joined the SCOT trial, the first site opened with 2 patients recruited.
We are very pleased to let you know that a late-breaking abstract for the COG trial has been accepted for presentation at the ESMO Conference in Vienna this September. As a means of reviewing the abstract prior to the conference and notifying sites of the initial findings of the trial, an Investigator Meeting is going to be held on Monday 17th September, and sites will be contacted regarding this in due course. During the meeting, Professor David Ferry and statistician Sue Dutton will present the abstract and listen to any feedback/comments that you might have. We look forward to sharing the results of this important trial with site staff who have worked so hard on it.
We are counting down the remaining CRFs to be submitted with our first post end of follow up data lock imminent on the 13th July.
We are delighted that the CHOP-OR trial remains on target with 15 patients now recruited.
Recruitment is going to be extended until 2014 and more information will follow via email.
6MP has recruited 25 patients. Our target is 48 patients by the end of July 2012. The trial is open to patients with known BRCA1 & 2 deficient locally advanced or metastatic breast cancer, advanced ovarian, fallopian tube or primary serous peritoneal cancer patients who have progressed after at least 1 previous line of chemotherapy. Analysis of the first 12 patients' safety data showed that the IMP is being well tolerated with no safety issues.
From Monday 18th June the AspECT trial lab will be open to accept blood and biopsy samples from all AspECT sites. The trial lab is now staffed by Neera Maroo and Barbara Zietek. If you need trial sample supplies, please email email@example.com or firstname.lastname@example.org
The lab address will remain the same (Blizard Institute).
The EnROL trial is now in the last month of patient follow up could all sites please ensure all data is submitted as soon as possible.
The EnROL trial management group has submitted and had accepted for publication a paper that described the design and methodology of the EnROL Trial. The paper will be published in BMC cancer.
Happy 1st Birthday to the CHOP-OR trial. The trial opened to recruitment on the 27th April 2011 so we are now into the 2nd year of recruitment.
Just 8 patients needed to reach recruitment target.
SCOT recruitment in Denmark is going well, 7 sites opened and 43 patients recruited since November 2011.
6MP has recruited 20 patients. We are aiming to recruit 33 patients by the end of April 2012. The trial is open to patients with known BRCA1 & 2 deficient locally advanced or metastatic breast cancer, advanced ovarian, fallopian tube or primary serous peritoneal cancer patients who have progressed after at least 1 previous line of chemotherapy.
The first 12 patients’ safety analysis is underway and the results will be discussed by the trial committees at meetings in May. Many thanks for your valuable input to this important trial.
Aspirin for Cancer Prevention
Fresh evidence suggests that taking a low dose aspirin every day may prevent and possibily even treat cancer. The three new studies published by Peter Rothwell in The Lancet add to mounting evidence of the drug's anti-cancer effects. The AspECT Trial Management Group reviewed the latest evidence and immediately released a statement to all trial site staff.
If you are an AspECT patient and have any questions about this please contact the AspECT team at your recruiting hospital.
If you work on the AspECT trial at one of our sites please refer to the additional information here http://www.octo-oxford.org.uk/alltrials/infollowup/aspect/restricted.html
Professors Peter Rothwell and Janusz Jankowski were interviewed on this issue for the BBC Radio 4 programme 'Inside Health', presented by Dr Mark Porter, which was broadcast on 27th March 2012. You can download the programme here.
Professor Jankowski was also interviewed by Derek Bateman for BBC Radio Scotland's Newsweek programme. You can download the programme here.
Temporary ~ 3 month sample collection suspension for AspECT.
CHOP-OR CHOP-OR Trial has hit its first milestone 3 months ahead of target with the 10th patient being recruited in January 2012, just 9 months after the first site was opened to recruitment. We thank all participating sites especially Addenbrooke’s and Royal Bournemouth who have both entered 4 patients each.
The SONATINA Team are pleased to report that all 8 patients have now been randomised into the Safety Cohort of the SONATINA trial. We would like to thank everyone involved with the recruitment of these patients onto the trial. Further recruitment to the trial is now on hold until the data from these patients is analysed in Spring 2012.
Protocol version 3 11Nov2011 and associated documents are now approved by MREC and MHRA. The amendment documents are available via CSP.
In October 2011, OCTO celebrated our 10th Anniversary! We've come along way since the office opened in 2001 with just three staff and a single trial. We currently have 9 actively recruiting trials, 3 in follow-up and more trials on the way in 2012.
Click on the link below to download a copy of our 10th Anniversary Newsletter which contains lots of information about OCTO and our trials.
COG recruitment phase is now closed having met the recruitment target. Final number recruited is 450 with 19 patients recruited during the first two weeks in November.
Protocol V5.0 has been approved by the main REC so the recruitment target for the trial is now 202.
We are pleased to announce that the Christie Hospital recruited their first patient into the EnROL trial.
We are pleased to announce that Denmark has become active in the trial with 1 site activated and 3 patients recruited.
In July 2011, NICE issued guidelines on the use of Radio-Embolisation in the treatment of liver metastases from colorectal cancer. NICE specifically named the FOXFIRE clinical trial as a "well-designed clinical trial" and used it as an example for others to follow in answering important research questions that may make a difference to the future treatment of patients with cancer. More information can be found at http://guidance.nice.org.uk/IPG401/DraftGuidance.
On the 1st October 2011 the EnROL trial entered into its final 6 months of recruitment. We are delighted that in October we hit our monthly recruitment target of 8 patients, just 40 patients left to go to hit our target.
Congratulations! With only 50 patients to go, we would like to extend our special thanks to our top recruiter sites:
We are pleased to announce that the EnROL trial has now recruited 152 patients with only 50 patients left to recruit.
We are pleased to announce that Spain has become active in the trial with 12 sites activated and 12 patients recruited during August.
CTAAC have approved our proposed reduction in sample size. An amended protocol will be submitted to ethics.
We are pleased to announce that the Christie Hospital recruited their first patient into the CHOP-OR trial.
SONATINA is study of nelfinavir addition to radiotherapy treatment in neo-adjuvant therapy for rectal cancer and is now open to recruitment at the Churchill Hospital.
6MP is a study of 6-mercaptopurine (6MP) and low-dose methotrexate in patients with BRCA defective breast or ovarian tumours and is now open for recruitment at the Churchill Hospital.
Congratulations! We are delighted to inform you that SCOT has now reached a significant milestone in our recruitment of 2000 patients.
A new study suggests that taking low doses of aspirin for at least five years can reduce the risk of dying from cancer. If people are considering taking aspirin on a regular basis, they need to weigh up the benefits and risks. The new study, published in the Lancet, was led by Professor Peter Rothwell. CRUK spoke to Professor Janusz Jankowski, the CI for the AspECT trial which is looking at whether aspirin can prevent oesophageal and bowel cancer. Here are his opinions and concerns about the latest findings.
COG is now over the half way mark, thank you for your ongoing support. Wishing everyone a very safe and joyful Xmas.
Oral bisphosphonates: oesophageal cancer risk—insufficient evidence of a link.
The last day to approach patients about QUASAR 2 will be 30th September 2010. You will then have until 17:00 (GMT) on October 15th to randomise them, after which time the database will lock and no further patients can be accepted. If you have any questions, please contact the QUASAR 2 team on 01865 617013.
Recruitment over the summer months for the SCOT trial has went very well. Thank you to everyone for your continued support and enthusiasm for the the SCOT trial! We are delighted to be fast approaching our 1,500th patient recruited. If each site recruits just 2 patients per month into SCOT we will reach our recruitment target of 9500 patients on schedule. Your contribution is invaluable. If you have any questions regarding the trial, please don't hesitate to contact us, we are always very happy to help.
The SCOT Team
We are pleased to announce that Charing Cross is now open to recruitment.
FOXFIRE Protocol V2.0 has been approved
We are pleased to announce that the EnROL Trial is now open to recruitment at Leighton Hospital
We are pleased to announce that Queen Alexandra Hospital, Portsmouth, is now open to recruit patients into the EnROL Trial.
QUASAR 2- Stage II patient randomisation closed.
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.
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
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.
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.
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
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
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 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.
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.
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.**"
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.
We are delighted to announce that University Hospital of North Tees has been activated to recruit patients into EnROL.
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
The number of CT scans mandated by the protocol is currently under review.
Click here for further details about the trial.
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.
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.
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.
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.
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.
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 has now 3 active sites and 3 patients recruited.
COG has received MHRA -CTA Approval and a Provisional Favourable Ethics Opinion, awaiting Final Approval. Site set-up is in progress.
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.
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).
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.