We designed the EURAMOS-1 trial to investigate whether intensified .. and a normal creatinine concentration for their age as per protocol. EURAMOS-1, an international randomised study for osteosarcoma: Results from Pre-operative chemotherapy was completed according to protocol in 94%. The EURAMOS 1 trial is a multimodal therapy of osteosacoma with precluding treatment with protocol chemotherapy (for example HIV.
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Planning the size and duration of a clinical trial studying the time to some critical event. Deffenbaugh13 C. Jundt24 L. Gosheger20 R. EURAMOS-1 was notable for addressing randomised questions in a rare cancer on an unprecedented scale and for launching at a time of profound change to European legislation related to trial regulation and governance [ 6 ].
Concordance with protocol chemotherapy was excellent. There were limits to the accessibility of the trial for osteosarcoma patients. With patients with resectable osteosarcoma randomised, it doubled the size of the previous largest RCT in this population and accrual was completed in around 6 years.
Bielack2 N. Osteosarcoma pprotocol was revolutionised by the introduction of adjuvant combination chemotherapy, in the s, but has improved little since. CTCAE grade 3—4 toxicity was common: Teot38 M. Once histological response to pre-operative chemotherapy has been evaluated, patients will be randomized by contacting the relevant trials center.
The pre-operative toxicities reported were as expected. A successor study has not yet emerged eursmos willingness by investigators and other trials groups joining the collaboration to face the formidable regulatory and financial challenges which must be overcome.
Surgery will be performed after 10 weeks of pre-operative chemotherapy. University Hospital of Muenster, Muenster, Germany. Randall35 P. Author information Article notes Copyright and License information Disclaimer. Improvement in the following outcomes Overall survival Short-term toxicity Long-term toxicity Quality of life.
Calaminus11 M. Commencing Marchpatients were registered from centres across 17 countries. Capra12 C.
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Survival from high-grade localised extremity osteosarcoma: Read Article at publisher’s site. Letson28 J. Or filter your current search.
Patients were randomised after surgery. Therefore, this study addressed separate treatment questions based on histological response.
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Response classification was dichotomised: Cure of osteosarcoma in a proportion of patients was consistently reported first in the s, achieved through the combination of surgical extirpation of the primary tumour with multi-drug chemotherapy. Jovic6 J. For commercial re-use, please prptocol journals. At the time of trial planning, few data were available to guide a sample size calculation to accurately estimate randomisation rates and these were markedly lower than expected, which contributed to 11 decision to expand registration targets from to over Flanagan16, 17 H.
Considerable regulatory, financial and operational challenges must be overcome to develop similar studies in the future.
This paper describes the full, registered patient population, including all patients who signed the informed consent documents, up to the point of surgery. We were unable to open EURAMOS-1 in some countries that wished to participate either because of protocok constraints or insufficient funding.
Dhooge14 M. Infour clinical study groups agreed to collaborate to conduct osteosarcoma studies more rapidly.