Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
11/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Pat Cook

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
pat.cook@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TE09

Study information

Scientific title

Acronym

Study hypothesis

To define equivalent activity and lower toxicity of combination chemotherapy containing carboplatin rather than cisplatin

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

Not Specified

Patient information sheet

Condition

Cancer

Intervention

Arm 1 - 4 cycles BEP.
Arm 2 - 4 cycles CEB.

Intervention type

Drug

Phase

Not Specified

Drug names

Carboplatin

Primary outcome measures

Complete remission on chemotherapy or chemotherapy + surgery. Progression-free survival. Survival, toxicity.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1989

Overall trial end date

31/12/1993

Reason abandoned

Eligibility

Participant inclusion criteria

Histologically confirmed non-seminomatous germ cell tumour of testis or combined seminoma/teratoma or seminoma with unequivocal raised serum alpha feto protein concentration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

450

Participant exclusion criteria

Previous chemotherapy.

Recruitment start date

01/06/1989

Recruitment end date

31/12/1993

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=9164194

Publication citations

  1. Results

    Horwich A, Sleijfer DT, Fosså SD, Kaye SB, Oliver RT, Cullen MH, Mead GM, de Wit R, de Mulder PH, Dearnaley DP, Cook PA, Sylvester RJ, Stenning SP, Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial., J. Clin. Oncol., 1997, 15, 5, 1844-1852.

Additional files

Editorial Notes