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

Miss Sharon Naylor

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TE12

Study information

Scientific title

Acronym

Study hypothesis

Compare the efficacy of carboplatin with a combination of etoposide and cisplatin in the treatment of advanced metastatic seminoma.

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 of carboplatin.
Arm 2 - 4 cycles of cisplatin/etoposide.

Intervention type

Drug

Phase

Not Specified

Drug names

Carboplatin versus Etoposide / Cisplatin

Primary outcome measures

Progression-free survival

Secondary outcome measures

Response, survival, toxicity.

Overall trial start date

01/08/1990

Overall trial end date

31/12/1995

Reason abandoned

Eligibility

Participant inclusion criteria

Histologically verified testicular/extra-gonadal pure seminoma

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

112

Participant exclusion criteria

Previous chemotherapy.

Recruitment start date

01/08/1990

Recruitment end date

31/12/1995

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?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11104556

Publication citations

  1. Results

    Horwich A, Oliver RT, Wilkinson PM, Mead GM, Harland SJ, Cullen MH, Roberts JT, Fossa SD, Dearnaley DP, Lallemand E, Stenning SP, , A medical research council randomized trial of single agent carboplatin versus etoposide and cisplatin for advanced metastatic seminoma. MRC Testicular Tumour Working Party., Br. J. Cancer, 2000, 83, 12, 1623-1629, doi: 10.1054/bjoc.2000.1498.

Additional files

Editorial Notes