News
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
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.
October 2008
EURAMOS-1 Investigators Meeting (COG Fall Meeting)
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:
- Need for International Collaboration in Rare Diseases Stefan Bielack
- Osteosarcoma: EURAMOS-1 Study Mark Bernstein
- EURAMOS-1 Infrastructure Matthew Sydes
- 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:
- Obtaining Consent: a demonstration of the consent process with discussion. Lesley Fallowfield and Jeremy Whelan
- Improving Randomisation Rates: Practical steps. Dorothe Carrle
- SAE Reporting. Trude Butterfass-Bahloul
- Toxicity Reporting: Guide to CTCAE. Martha Perisoglou
- Role of the clinical trials pharmacist. Roy Sinclair
- Art in medicine. Lizzie Burns
- Quality of life. Gabriele Calaminus
- The importance of multi-national trials for rare diseases – the EURAMOS model. Matthew Sydes
- Funding pan-European trials: Role of ESF. Carole Moquin-Pattey
- European Clinical Research Infrastructures Network (ECRIN). Christine Kubiak
- 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
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.