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ISRCTN
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ISRCTN86294690
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ClinicalTrials.gov identifier
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Public title
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A randomised trial of chemotherapy with or without granulocyte colony-stimulating factor (G-CSF) in operable osteosarcoma
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Scientific title
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Acronym
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N/A
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Serial number at source
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BO06
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Study hypothesis
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To compare two regimens of chemotherapy using Doxorubicin and Cisplatin in operable osteosarcoma: one involving chemotherapy at three weekly intervals with surgery after two courses, the other, chemotherapy at two weekly intervals plus G-CSF with surgery after three courses.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Osteosarcoma
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Participants - inclusion criteria
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1. Untreated non-metastatic disease
2. Age less than or equal to 40 years
3. Neutrophils ≥1.5 times 10^9/l and platelets ≥100 times 10^9/l
4. Glomerular Filtration Rate (GFR) ≥60 ml/min/1.73 m^2
5. Serum bilirubin ≤ micromoles/L
6. Normal cardiac function
7. Informed consent
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/07/1993
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Anticipated end date
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30/09/2002
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Status of trial
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Completed
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Patient information material
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Target number of participants
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500
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Interventions
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Two regimens of chemotherapy:
1. The first is Doxorubicin and Cisplatin at three weekly intervals with surgery after two courses/chemotherapy.
2. The second is Doxorubicin and Cisplatin at two weekly intervals plus G-CSF with surgery after three courses.
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Primary outcome measure(s)
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1. Survival time
2. Response rate
3. Morbidity
4. Response duration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17227995
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Contact name
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Dr
Barbara
Uscinska
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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unknown@contact.com
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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28/02/2001
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Last edited
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06/03/2007
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Date ISRCTN assigned
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28/02/2001
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