The EURAMOS clinical trial, which involves a collaboration across 11 European countries, as well as the US and Canada, is on course to recruit some 1400 patients over the next few years to improve treatment for osteosarcoma, the most common bone cancer in children.
Doctors and scientists meeting at a conference in Stuttgart, Germany last week (30 November-2 December 2006) heard that recruitment for the trial was on track, with some 335 patients so far being treated within the trial.
The conference, ‘Pan European Sarcoma Trials – moving forward in a climate of increasing economic and regulatory pressure’, represented a unique gathering of experts in the field of the type of cancer called sarcomas.
Professor Stefan Bielack, the co-ordinator of the EURAMOS trial, told the meeting, “While sarcomas are rare, accounting for less than one per cent of all cancers, they are some of the most frequent that occur in childhood and adolescence. Treatment is complex and collaboration between many centres and different countries is crucial.”
The EURAMOS study brings together three existing European collaborations that are examining treatments for sarcomas, and one North American group. EURAMOS – an acronym for the European and American Osteosarcoma Study Group – is being funded through the European Science Foundation’s EUROCORES (European Collaborative Research) programme on pan-European Clinical Trials (ECT).
People with osteosarcoma are usually first given chemotherapy before the tumour is surgically removed, followed by another course of chemotherapy. The effect of the initial course of chemotherapy can vary however; in some cases there is a good response and in others a poor response. This can have a bearing on the ultimate outcome of the treatment, with poor responders to the initial course of chemotherapy tending to have a worse chance of surviving the disease. The EURAMOS trial will examine a different treatment regime for ‘poor responders’ to see if survival rates can be improved.
The Stuttgart conference, attended by nearly 200 delegates from across the world, heard that new regulations governing clinical trials, introduced by the European Union, had caused difficulties but in the case of EURAMOS these hurdles had successfully been cleared. The clinical trials directive introduced by the EU and aimed at harmonising administrative provisions governing clinical trials across the Union and introducing greater protection for patients had unwittingly created a number of obstacles to establishing non-commercial clinical trials.
“Unfortunately the type of trials that we undertake to improve therapies using existing drugs now fall under the same regulations as trials by the pharmaceutical industry investigating novel agents,” said Professor Bielack. “This has created many legal and bureaucratic difficulties, especially in setting up trials across national boundaries. It has also made trials far more expensive than in the past.”
Dr Kathy Pritchard-Jones, President-elect of SIOP Europe, the European branch of the International Society of Paediatric Oncology, said, “The aims of the EU’s clinical trials directive are entirely laudable, but there have been unforeseen consequences that have led to delays in establishing trials. And while there is no doubt that clinical trials are now better constructed under the new regime, we do need a more rational approach to a number of aspects of non-commercial clinical trials.”
Dr Heribert Jürgens, immediate past-president of the German Society for Paediatric Oncology and Haematology, told the conference, “The EU regulations were designed to promote better research and protect the subjects. We have to accept and apply them, and establish centralised structures and standardised procedures.”
The issue of the use of medicines in paediatric clinical trials was also discussed. Professor Paolo Paolucci, chairman of the Therapeutic Expert Group in Oncology of the Taskforce in Europe for Drug Development for the Young (TEDDY), said, “The objectives of the EU directive are important to increase development of medicines in children.” TEDDY’s role is to promote the availability of safe and effective medicines for children in Europe by integrating existing expertise and good practice. As a ‘network of excellence’ it has more than 100 doctors and scientists with an interest in sarcomas, Professor Paolucci said.
The conference also heard of many new advances in the diagnosis and treatment of sarcomas, from molecular genetic techniques to determine precisely which type of cancer was present, to the latest radiotherapy technologies and new methods for removing secondary tumours from the lung with lasers. The conference was also told how as survival rates for sarcomas continue to improve, issues of quality of life of patients are becoming increasingly important, while remaining challenging to quantify precisely and objectively.
Dr Mariana Resnicoff, co-ordinator of the ESF EUROCORES programme in medical sciences, said that the conference had demonstrated the importance of pan-European collaborations in academic trials aimed at developing new modalities in the treatment of sarcoma. Dr Resnicoff added, “EURAMOS has succeeded in overcoming the hurdles imposed by the implementation of the EU Clinical Trials Directive and the experience gathered throughout the launch of this trial can be used as a model to pave the way for further pan-European academic clinical trials in the future.”
The European Science Foundation (ESF) provides a platform for its Member Organisations to advance European research and explore new directions for research at the European level. Established in 1974 as an independent non-governmental organisation, the ESF currently serves 78 Member Organisations across 30 countries.
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