International Study for the Salvage Treatment of Germ Cell Tumours

ISRCTN	ISRCTN11143611
DOI	https://doi.org/10.1186/ISRCTN11143611
Protocol serial number	GE301
Sponsor	Institut Gustave-Roussy (France)
Funder	Institut Gustave-Roussy (France)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Testis
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cancer drugs
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	Male
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	15/01/1994
Date of final enrolment	31/12/2004

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan