Condition category
Cancer
Date applied
11/08/2004
Date assigned
22/10/2004
Last edited
10/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Robert Huddart

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2004-000405-22

ClinicalTrials.gov number

NCT00301782

Protocol/serial number

MRC TE23 Study, Version 1.0

Study information

Scientific title

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Phase II

Drug names

Bleomycin, carboplatin, cisplatin, etoposide phosphate, vincristine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2005

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Non-seminomatous germ cell tumour of any extracranial primary site
2. Poor prognonsis features, as defined by 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 type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

88

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2005

Recruitment end date

01/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.centre-london.mrc.ac.uk/

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25001888

Publication citations

  1. Results

    Huddart RA, Gabe R, Cafferty FH, Pollock P, White JD, Shamash J, Cullen MH, Stenning SP, , A Randomised Phase 2 Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP in Poor-prognosis Germ Cell Tumours (MRC TE23, CRUK 05/014, ISRCTN 53643604)., Eur. Urol., 2014, doi: 10.1016/j.eururo.2014.06.034.

Additional files

Editorial Notes