Randomised phase II trial comparing intensive induction chemotherapy (CBOP BEP) with standard BEP chemotherapy in poor prognosis male germ cell tumours

ISRCTN	ISRCTN53643604
DOI	https://doi.org/10.1186/ISRCTN53643604
EudraCT/CTIS number	2004-000405-22
ClinicalTrials.gov number	NCT00301782
Secondary identifying numbers	MRC TE23 Study, Version 1.0

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Dr Robert Huddart
Scientific

Institute of Cancer Research and Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	-
Study acronym	TE23
Study hypothesis	Not provided at time of registration More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=38
Ethics approval(s)	Not provided at time of registration
Condition	Male non-seminoma germ cell tumours (NSGCT)
Intervention	Patients will be randomly allocated either the 'gold standard' BEP (bleomycin, etoposide and cisplatin) chemotherapy or the intensive induction regimen CBOP/BEP (carboplatin, bleomycin, vincristine, cisplatin, etoposide).
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Bleomycin, carboplatin, cisplatin, etoposide phosphate, vincristine
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2005
Overall study end date	01/06/2010

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target number of participants	88
Total final enrolment	89
Participant inclusion criteria	1. Non-seminomatous germ cell tumour of any extracranial primary site 2. Poor prognosis features, as defined by the International Germ Cell Cancer Collaborative Group (IGCCCG) criteria 3. Performance status 0 - 3 4. Globular filtration rate greater than 50 ml/min 5. No comorbid condition
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/06/2005
Recruitment end date	01/06/2010

Institute of Cancer Research and Royal Marsden Hospital

Sutton
SM2 5PT
United Kingdom

Medical Research Council (MRC) (UK)
Government

c/o Dr Ian Viney
MRC Centre London
Stephenson House
158-160 North Gower Street
London
NW1 2ND
United Kingdom

Website	http://www.centre-london.mrc.ac.uk/
"ROR"	https://ror.org/03x94j517

Charity

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2015		Yes	No
Results article	results	01/03/2020	03/02/2020	Yes	No
Plain English results			25/10/2022	No	Yes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
03/02/2020: Publication reference added.