Treatment of good prognosis germ cell cancer

ISRCTN	ISRCTN35399995
DOI	https://doi.org/10.1186/ISRCTN35399995
Protocol serial number	TE20
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Pat Cook
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email	pat.cook@ctu.mrc.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To compare 3 x BEP and 3 x BEP + 1 x EP and the five day schedule versus three days per cycle in good prognosis germ cell cancer
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Testicular cancer
Intervention	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
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Several
Primary outcome measure(s)	1. Time to progression 2. Quality of life 3. Morbidity 4. Survival time
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/1998

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	800
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/1995
Date of final enrolment	01/05/1998

MRC Clinical Trials Unit

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/03/2001		Yes	No
Results article	results	15/03/2003		Yes	No