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ISRCTN
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ISRCTN11143611
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ClinicalTrials.gov identifier
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Public title
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International Study for the Salvage Treatment of Germ Cell Tumours
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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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GE301
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Study hypothesis
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Not provided at time of registration
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Lay summary
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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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International
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Disease/condition/study domain
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Testis
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Participants - inclusion criteria
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1. Males aged >16 years
2. Germ cell tumours, either testicular or extragonadal
3. Platinum combination chemotherapy as first line chemotherapy
4. Remission after complete response from first line chemotherapy
5. Partial responder patients after first line chemotherapy, including patients with resection of viable malignancy after first line chemotherapy with elevated tumour markers
6. World Health Organisation (WHO) performance status grade 0-2
7. Seminoma patients relapsing after complete response after cisplatin-based chemotherapy or partial response under cisplatin-based chemotherapy
8. Refactory patients are to be excluded
9. Patients with pure seminoma treated with carboplatin are excluded
10. No other malignancy
11. No medical contraindications to protocol treatments
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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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15/01/1994
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Anticipated end date
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31/12/2004
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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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Not provided at time of registration
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Interventions
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1. Group A: Chemotherapy with etoposide, ifosfamide, mensa and CDDP (PEI) or etoposide, ifosfamide, mensa and CDDP (VEIP). Treatment cycle repeated every 21 days for four cycles.
2. Group B: Chemotherapy with PEI or VEIP. Treatment cycle repeated every 21 days for three cycles followed by myeloablative chemotherapy with carboplatin, etoposide, cyclophosphamide and mensa (CarboPec) plus ABMT/PBSC.
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Primary outcome measure(s)
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Not provided at time of registration
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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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Institut Gustave-Roussy (France)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
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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Tel
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+44 (0) 207 670 4723
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Fax
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+44 (0) 207 670 4818
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Email
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Sponsor
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Institut Gustave-Roussy (France)
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Address
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39 rue Camille Desmoullins
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City/town
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Villejuif Cedex
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Zip/Postcode
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94805
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Country
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France
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Tel
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+33 (0) 1 42114211
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Fax
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+33 (0) 1 42115300
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Email
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roussy@igr.fr
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Sponsor website:
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http://www.igr.fr
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Date applied
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19/08/2002
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Last edited
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19/05/2008
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Date ISRCTN assigned
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19/08/2002
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