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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN35399995 |
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Date of registration:
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28/02/2001 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of good prognosis germ cell cancer
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Scientific title:
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Date of first enrolment:
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01/05/1995 |
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Target sample size:
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800 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN35399995 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Pat
Cook |
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Address:
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MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Telephone:
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Email:
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pat.cook@ctu.mrc.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Seminoma or non-seminoma - testis or retroperitoneal primary, alpha-fetoprotein (AFP) =1000 iu/l human chorionic gonadotrophin (HCG) =5000 iu/l, lactic dehydrogenase (LDH) =1.5 x N
2. No liver, bone or brain mets seminoma - stage =2 C or relapse after radiotherapy and any primary site and LDH
3. No liver bone or brain mets
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Testicular cancer
Cancer
Testicular
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Intervention(s)
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There are four groups:
1. The first receives three cycles of BEP chemotherapy over a five day schedule
2. The second group receives three cycles of BEP + 1 cycle of EP chemotherapy over a 5 day schedule
3. The third group receives three cycles of BEP over a 3 day schedule
4. The fourth group receives three cycles of BEP over a 3 day schedule plus one cycle of EP
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Primary Outcome(s)
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1. Time to progression
2. Quality of life
3. Morbidity
4. Survival time
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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