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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: |
ISRCTN11143611 |
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Date of registration:
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19/08/2002 |
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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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International Study for the Salvage Treatment of Germ Cell Tumours
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Scientific title:
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Date of first enrolment:
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15/01/1994 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN11143611 |
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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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France
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Contacts
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Name:
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
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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Testis
Cancer
Testicular
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Intervention(s)
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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(s)
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Not provided at time of registration
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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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Institut Gustave-Roussy (France)
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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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