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November 2014

EURAMOS-1 Poor Responders CTOS Presentation and MRC CTU Article

Based on the data presented to the IDMC on the 19th June 2014 it was recommended that data be released for the Poor Responders randomisation. This recommendation was approved by the Trial Steering Committee at the end of July. Investigators were subsequently informed through their respective Data Centres in August with further information being presented on the relevant websites.

Dr. Neyssa Marina presented the Poor Responders results at CTOS on Friday 17th October. To coincide with the presentation the Medical Research Council  Clinical Trials Unit posted an article on its website. You can view the article by clicking on the link here. A full analysis will follow soon.



October 2014

EURAMOS-1 Papers

The PI and Collaborating Groups list for the EURAMOS-1 papers can be found here.


November 2013

A Reminder of the Pan-European Clinical Trials (ECT) Final Report
You can view the European Science Foundation's Report by clicking here. The report outlines the ESF's current involvement in collaborative research projects, including EURAMOS-1.


July2013

Presentation of Good Responders Results to Investigators
Stefan Bielack presented the results of the Good Responders randomisation in a teleconference to Investigators on Tuesday 30th July. The presentation was recorded and can be downloaded to view here. A password is required to open this document which EURAMOS-1 National Coordinators will soon be circulating to their country's Principal Investigators. If you have not received this password please contact your Data Centre.


June 2013

First results of the EURAMOS-1 Good Response randomisation presented at ASCO 2013.

Professor Stefan Bielack presented the results of the good response randomisation to ASCO attendees on Monday the 3rd June. The video presentation can be viewed by ASCO members here.  Those who are subscribed to ASCO's Oncology Slide Library can view the the presentation slides  here. The presentation should be available publicly in approximately six months.
The abstract submitted to ASCO for the first results of the EURAMOS-1 good-response randomisation can be viewed by all here. The paper on the good response randomisation will be out later in the year.

First results of the EURAMOS-1: Information for trial participants and families

First results from EURAMOS-1 were presented at the ASCO conference in Chicago, USA on 3rd June 2013. Click here for more.


February 2013

EURAMOS-1 in The European Science Foundation's (ESF) Report on Pan-European Clinical Trials

The ESF has provided a report outlining its current involvement in collaborative research projects, which includes EURAMOS-1. Click here to view the report.


December 2012

SAEs over the Christmas Reporting Period

Please note that SAE reporting will continue as normal over the Christmas period. Please submit all SAEs to the Safety Desk using fax number +49 (0)251 83 57112


August 2012

EURAMOS (mis-)quoted in the British Journal of Cancer

 
Following the end of recruitment into EURAMOS-1 and after careful review of the literature, the Trial Management Group stated that the recommended current standard of care for newly diagnosed patients with resectable osteosarcoma outside of clinical trials should be MAP (methotrexate, doxorubicin, cisplatin) with no adjustment of post-operative treatment based on histological response. This recommendation is still held upright today, a year later, whilst the results of EURAMOS-1 are awaited.
The TMG knows well that this recommendation is not in line with the considerable and remarkable marketing activities surrounding a macrophage activator which has meanwhile become available throughout much of Europe. A recent publication in the British Journal of Cancer about medicines for orphan indications in oncology now focuses on this new drug and on osteosarcoma.1 Its authors state that they intend to “exemplify challenges that innovators can face” when introducing new treatments. Fear that the viability of the EURAMOS trial would be impaired if more osteosarcoma patients were able to access the new drug is alluded to as a “perverse reason for delaying marketing approval”.1
 
A letter to the editor from within the EURAMOS Trial Management Group2 clarifies that the “partial introduction of the drug” to date much less “exemplifies barriers that the makers of orphan cancer medications have to overcome during the drug development and supply process”, as Davies et al wish to convince their readers, than a considerable amount of scepticism regarding the drug’s efficacy. Of course, including such thoughts into their discussion might have made it much more challenging to find a sponsor for the manuscript. As is, the first author received indirect funding for the paper by the license holder of the drug in question, who also funded open access publication.1
 
References:
1.      Davies JE, Neidle S, Taylor DG (2012) Minireview: Developing and paying for medicines for orphan indications in oncology: utilitarian regulation vs equitable care? Br J Cancer 106: 14 – 17
2.      Bielack S (2012) Comment on 'Developing and paying for medicines for orphan indications in oncology: utilitarian regulation vs equitable care?' Br J Cancer Jun 28. doi: 10.1038/bjc.2012.280. [Epub ahead of print]



July 2012

EURAMOS-1 ASCO 2012 Poster Now Available to view

Click here to view the EURAMOS-1 poster that was presented at this year's ASCO conference.

‘2nd International Meeting on Future Clinical Trials for the Adjuvant Treatment of Osteosarcoma: Creating a Strategic Consensus’ - Final Report now Available to view

The final report for the European Sarcoma Strategy Group meeting held in February is now available to view. Please click here to open the document.


May 2012

EURAMOS-1 at ASCO 2012

Our abstract ‘EURAMOS-1 study: recruitment, characteristics and initial treatment of >2000 patients (pts) with high-grade osteosarcoma’ has been accepted for presentation at the 2012 ASCO Annual Meeting in Chicago. Please click here to view the abstract with details of the session time and location.  

If you’re attending the conference, come and see our poster in the Sarcoma General Poster Session, Sunday 3rd June 0800-1200, S Hall A2.



February 2012

On Monday the 27th and Tuesday the 28th February The European Sarcoma Strategy Group met at the Royal Institute of British Architects in London for the ‘2nd International Meeting on Future Clinical Trials for the Adjuvant Treatment of Osteosarcoma: Creating a Strategic Consensus’.

The aim of the meeting was to agree a coordinated research program to support the development of an international multi-arm multi-stage clinical trial in patients with newly diagnosed osteosarcoma.



December 2011

Accrual complete in EURAMOS-1!


EURAMOS-1 has reached a major milestone! Accrual is now complete. The first patient was entered in April 2005. The trial closed to registrations on 30 June 2011 and randomisations are now complete. In the whole trial, 2260 patients have been registered and 1332 have been randomised.

This is a major achievement as EURAMOS-1 is the largest osteosarcoma study ever conducted. Osteosarcoma is a rare disease and reaching the accrual target was possible thanks to a successful collaboration between the different participating groups worldwide.

Click here for the EURAMOS-1 Group Newsletter



November 2011

Accrual complete in EURAMOS-1!

EURAMOS-1 has reached a major milestone! Accrual is now complete. The first patient was entered in April 2005. The trial closed to registrations on 30 June 2011 and randomisations are now complete. In the whole trial, 2260 patients have been registered and XXX have been randomised.

This is a major achievement as EURAMOS-1 is the largest osteosarcoma study ever conducted. Osteosarcoma is a rare disease and reaching the accrual target was possible thanks to a successful collaboration between the different participating groups worldwide.

Click here for the EURAMOS-1 Group Newsletter



July 2011

EURAMOS-1 closed to registration on 30 June 2011. In the whole trial, 2260 patients have been registered and 1278 patients randomised to date. Randomisations will remain possible for all registered patients until they have been randomised or it is confirmed that they will not be randomised.
Click here for the EURAMOS-1 Group Newsletter

Dexrazoxane: restriction of use in the European Union

On 23 June 2011, the European Medicines Agency issued an opinion following a review of the safety and effectiveness of dexrazoxane.

In the European Union, dexrazoxane is now contraindicated for use in children and adolescents up to age 18 years due to evidence of serious harm (increased risk of secondary acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS)) in this age-group. Use is restricted to adults with advanced or metastatic breast cancer who have previously received a minimum cumulative dose of 300 mg/m2 doxorubicin or 540 mg/m2 epirubicin. The recommended dose ratio for dexrazoxane used in combination with doxorubicin is 10:1. Dexrazoxane is no longer indicated for use in patients with malignancies other than breast cancer.

Therefore, dexrazoxane should not be used in EURAMOS-1 patients from the European Union. 

http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Dexrazoxane_31/WC500108011.pdf
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Dexrazoxane/human_referral_000277.jsp&mid=WC0b01ac0580024e99&murl=menus/regulations/regulations.jsp


June 2011

Closure to registration at the end of June 2011

EURAMOS-1 trial will close to registrations at the end of June 2011. Randomisations will remain possible for all registered patients until they have been randomised or it is confirmed that they will not be randomised.

Appendix B

The amendment of appendix B (version 3.0 – 19 April 2011) for EURAMOS-1 has been approved in the UK (MREC approval on 17.05.2011 and MHRA approval on 20.05.2011). This amendment was made mainly to update the trial documentation to reflect the Schering-Plough and Merck merger. Labels, PIS, consent forms and pharmacy instructions have been updated accordingly and are available on the website in the ‘participating institutions’ section.

MRC CTU update

The MRC CTU is moving offices on 1st July 2011. From 1st July, please send every communication to MRC CTU, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. In addition, we would like to welcome in the EURAMOS-1 team Karen Sanders, who has taken over from Nicola Kaganson as Clinical Project Manager and Aurélie Faysse who is the new EURAMOS-1 trial manager.


May 2011

EURAMOS-1 at EMSOS

A presentation about the EURAMOS-1 study was given by Prof. Stefan Bielack at the 24th European Musculo-Skeletal Oncology Society (EMSOS) Annual meeting in Belgium in May 2011: 'Osteosarcoma treatment in Europe and elswhere is far from being centralised: lessons from EURAMOS-1.'

Please click here to view the presentation



June 2010

EURAMOS-1 at ASCO 2010:

The Quality of Life Co-ordinating Centre presented a poster on the 'first results of the pre-surgery treatment period'. Please click here to see the poster.


March 2010

Future Clinical Trials for Adjuvant Treatment of Osteosarcoma – Prioritising the Questions

With the EURAMOS-1 trial already having recruited more than two-thirds of its patients and with less than 1 year left until the end of patient recruitment, the EURAMOS collaborators are keen  to develop strategies on how to continue performing successful multinational trials for patients with osteosarcoma. This may only be accomplished together with other investigators and groups who are facing similar challenges as well as with trial support networks.
To this end, a two-day international conference was held in London, UK on the 15th and 16th March 2010 to reflect on recent considerations, review pertinent questions and consider how best to work to address outstanding clinical questions.
Around fifty clinicians, statisticians and trialists participated in the meeting, representing leading osteosarcoma research groups from all over the world including ASSG, COG, COSS, EOI, EORTC, EURAMOS, GEIS, ISG, JCOG, SARC, SFCE and SSG.

Click here for more information on the Bone Planning Meeting...


1000th EURAMOS-1 Patient Randomised

EURAMOS-1 has reached an important milestone by randomising its 1000th patient. This took place on the 29th March 2010 at the University of Miami, School of Medecine, USA, participating via the Children's Oncology Group (COG).

Thank you to all participating centres for helping to achieve this important goal, and for your continued support of the EURAMOS-1 trial.


November 2009

Dr. Dorothe Carlle recently gave a presentation on the EURAMOS-1 collaboration at the 15th Annual Meeting of Connective Tissue Sarcoma Society (CTOS) in Miami, Florida between the 5th and 7th November 2009

CTOS is an international group comprised of physicians, scientists and clinical investigators with a primary interest in the tumours of connective tissues. The 15th Annual Meeting of CTOS was held in Miami and attended by more than four hundred sarcoma experts from various specialities all over the world. The presentation was part of the session on adolescent and young adult sarcomas and was and excellent opportunity to inform about the progress and success of the EURAMOS-1 trial.

Please click here to open presentation

        


May 2009

Peg-Intron for good responders


Mark Bernstein, Chief Investigator for the COG group, has provided a very useful paragraph on the use of interferon therapy in the treatment of osteosarcoma along with several useful links to supporting publications.

Please click here to open the document.


March 2009

Team Update


EURAMOS-1 Trial Manager Monique Tomiczek has left the MRC CTU for a year to go travelling. We would like to take this opportunity to thank Monique for all her hard work on the trial and wish her the best for the coming year!

Sarah Beall has now joined the EURAMOS-1 team as Trial Manager. Her contact details can be found below:

T: +44 (0)207 607 4617
E: euramos@ctu.mrc.ac.uk
F: +44 (0)207 670 4818


March 2009

We would like to draw your attention to the following conference:

EMSOS 2009: 14th – 15th May 2009. Stuttgart, Germany

The European Musculo-Skeletal Oncology Society (EMSOS) meeting will provide delegates with an opportunity to gain state of the art knowledge on the current diagnosis and treatment of bone and soft tissue sarcoma. This meeting is open to both EMSOS and non EMSOS members and is relevant to everyone working in the field of musculoskeletal tumour management.

Further information can be found on the EMSOS website here: http://www.emsos2009.de



April 2009

Recruitment to EURAMOS-1 has been extended until around June 2010


The target recruitment for EURAMOS-1 was a minimum of 1260 patients randomised to the trial; of these, 567 would likely be good responders and 693 poor responders. It was anticipated that around 1400 patients would need to be registered to achieve 1260 randomisations. However, there has been a lower than expected randomisation rate in the trial. This has been due to many reasons including disease progression, insufficient preoperative chemotherapy and withdrawal of consent. This means that more patients will need to be registered than first anticipated in order to achieve the required randomisation target of 1260 patients.

The decision therefore has been made by EURAMOS-1 Trial Management Group, in agreement with the Trial Steering Committee and Independent Data Monitoring Committee, to extend the recruitment period to EURAMOS-1 by approximately one year. This is based on calculations showing that around 2000 patients would need to be registered to attain the planned power for the trial’s main comparisons.

Based on experience in previous trials, the four participating groups expect to register around 400 patients per year in total. Thus, the trial will be extended by one year, so the expected closure date to registration will now be June 2010. The results of the primary outcome measure, event-free survival, should be known two to four years after the trial closes to accrual.

The amendment was approved by UK Ethics and Regulatory Authorities in early 2009. Submissions in collaborative international groups are currently in progress.


EURAMOS-1 Investigators meeting (COG Fall Meeting)

22nd October 2008, Denver, USA

To read more about the training course and to view the presentations click here.

22nd October 2008, Denver, USA.


Click here to view the Meeting Agenda.

If you would like to view the main presentations from the course, click on each of the following:

  1. Need for International Collaboration in Rare Diseases Stefan Bielack
  2. Osteosarcoma: EURAMOS-1 Study Mark Bernstein
  3. EURAMOS-1 Infrastructure Matthew Sydes
  4. Issues in Consent and Randomisation Dorothy Carrle & Jeremy Whelan

January 2008

Pan European Clinical Trials under current EU regulations: A training course for data managers, study nurses and junior clinical investigators.

24-25 January 2008, the Selsdon Park Hotel, South Croydon, London.

To read more about the training course click here.

Click here to view the final programme.

If you would like to view the main presentations from the course, click on each of the following:

  1. Obtaining Consent: a demonstration of the consent process with discussion. Lesley Fallowfield and Jeremy Whelan
  2. Improving Randomisation Rates: Practical steps. Dorothe Carrle
  3. SAE Reporting. Trude Butterfass-Bahloul
  4. Toxicity Reporting: Guide to CTCAE. Martha Perisoglou
  5. Role of the clinical trials pharmacist. Roy Sinclair
  6. Art in medicine. Lizzie Burns
  7. Quality of life. Gabriele Calaminus
  8. The importance of multi-national trials for rare diseases – the EURAMOS model. Matthew Sydes
  9. Funding pan-European trials: Role of ESF. Carole Moquin-Pattey
  10. European Clinical Research Infrastructures Network (ECRIN). Christine Kubiak
  11. GCP: Investigator responsibilities. Nicola Kaganson


February 2007

Bringing Medicine to Life: EURAMOS 1 patients take part in a unique art project by Dr Lizzie Burns

A project inspired by the MRC Clinical Trials Unit in collaboration with Dr Martha Perisoglou in the University College Hospital, London.

Bringing Medicine to Life is a unique project which encourages patients taking part in clinical trials to communicate their feelings and experiences through art. Ten patients with osteosarcoma, treated in the EURAMOS 1 trial, have participated in the art project so far.

Click here to read more about the Art Project.

The paintings and drawings of the EURAMOS 1 patients went on show for the first time at the international Pan European Sarcoma Trials conference in Stuttgart, Germany in November.

Click here to read about the exhibition at the Stuttgart conference.


January 2007

EOI trial results published

Results of the European Osteosarcoma Intergroup (EOI) (Click here to read more about the EOI) osteosarcoma trial (MRC BO06, EORTC 80931) have recently been published. The study assessed whether giving osteosarcoma patients chemotherapy at shorter intervals, by using 'growth factor' (G-CSF) as support, could result in longer survival for more patients compared to the same chemotherapy given at standard intervals.

Click here for more information about the MRC BO06 trial

Click here to view the results publication

Lewis IJ, Nooij M, Whelan J, Sydes MR, Grimer R, Hogendorn PCW, et al. Improvement in Histologic Response, But Not Survival, in Osteosarcoma Patients Treated With Intensified Chemotherapy: A Randomized Phase III Trial of the European Osteosarcoma Intergroup (MRC BO06, EORTC 80931, ISRCTN86294690). J Natl Cancer Inst 2006; 99:112-129.



November 2006

Pan European Sarcoma Trials : Moving forward in a climate of increasing economic and regulatory pressure

Conference

Stuttgart

30 November - 2 December 2006.

Click here to view news features for this event

Click here to view presentations from the Stuttgart conference.

Click here to read a news report about the conference in the Lancet Oncology

Click here to read the meeting report in Sarcoma


October 2006

Pan European Clinical Trials under current EU Regulations

A training course for data managers, study nurses and junior clinical investigators.

Holmenkollen Park Hotel Rica, Oslo, Norway.

5 - 6 October 2006.

Click here for full details of this event.


April 2006

EURAMOS 1 is now open to recruitment in all four collaborating groups!

EURAMOS 1 – A randomised trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy.

EURAMOS 1 is a collaboration between 4 of the worlds leading osteosarcoma research groups; the groups are the Cooperative Osteosarcoma Study Group (COSS); the Children’s Oncology Group (COG); the European Osteosarcoma Group (EOI) and the Scandinavian Sarcoma Group (SSG).

Recruitment has now commenced in all 4 groups and in a total of nine different countries, including, Germany, USA, UK, The Netherlands, Norway, Sweden, Belgium, Switzerland and Australia!

Please see the accrual section for detailed information regarding recruitment.


A new website for EURAMOS!

We have just launched this new website for EURAMOS. As you may have noticed, we have tried to improve many aspects of the old website. Some of the improvements we have made can be detailed as:

  • A new refreshing look to the site
  • New additional pages
  • Accessibility information
  • A Frequently Asked Questions (FAQs) section
  • A Sitemap
There are many more improvements to this site which we hope you'll notice whilst browsing.

We hope you like it.

If you have any comments about this webiste, or notice anything not quite right, then please email the Webmaster with your comments.