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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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TE21/EORTC 30983
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Randomised Phase II/III Study of Taxol-BEP versus BEP in patients with Intermediate Prognosis Germ Cell Cancer.
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Topic
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Cancer
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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EudraCT
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MREC N° |
MREC/98/6/79
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UKCRN ID |
734
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WHO ID
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Testis
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Phase |
III
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Current Status
| Closed - in follow-up |
| Closure Date | 25/08/2009 |
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Sample Size
| 500 |
| Accrual to Date |
 0% |
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Geographical Scope
| International Multi-Centre |
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Lead Country
| Non-UK country (also active in England) |
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Main Inclusion Criteria
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histologically proven germ cell cancer fulfilling criteria of the intermediate prognosis group
Age greater than or equal to 16 years and less than or equal to 50 years
WHO performance status 0, 1 or 2
Creatinine clearance less than or equal to 40ml/min
WBC less than or equal to 3.0x109/l
Platelets greater than or equal to 100x109/l
No previous chemotherapy
Able to comply with requirements of protocol and willing and able to give informed consent
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Main Exclusion Criteria
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Patients with all of the characteristics of the good prognosis group
Patients with any of the characteristics of the poor prognosis group
Previous chemotherapy
Patients with a second malignancy except basal cell skin cancer
Age younger than 16 or older than 50 years
Female sex
WHO-PS 3 or 4
Patients with renal function impairment; creatinin clearance less than 40ml/min, unless this is due to obstructive uropathy that can be relieved by nephrostomy
Patients with liver function impairment
Patients with pre-existing neuropathy
Patients with other serious illness or medical conditions incompatible with the protocol
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Chief Investigator(s)
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| Dr M Sokal | Ms Sally Stenning |
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Further details, please contact
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Mr Philip Pollock
Medical Research Council
Cancer Division
222 Euston Road
London
NW1 2DA
UNITED KINGDOM
Tel: 020 7670 4846
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Funder(s) |
Medical Research Council
European Organisation for Research and Treatment of Cancer (EORTC)
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Sponsor(s) |
European Organisation for Research and Treatment of Cancer (EORTC)
Medical Research Council
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