Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
31/01/2013
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

TE13

Study information

Scientific title

Acronym

Study hypothesis

Determine whether treatment with the intensive regimen BOP/VIP-B is more effective than BEP/P.
To determine the effect of G-CSF on the proportion of patients receiving full dose intensity of combination chemotherapy with either regimen.

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

Metastatic teratoma

Intervention

Arm 1 - Without granulocyte colony stimulating factor (G-CSF), BEP/EP.
Arm 2 - Without G-CSF, BOP/VIP-B.
Arm 3 - With G-CSF, BEP/EP.
Arm 4 - With G-CSF, BOP/VIP-B.

Intervention type

Drug

Phase

Not Specified

Drug names

Several

Primary outcome measures

Progression-free survival

Secondary outcome measures

Response rate, overall survival

Overall trial start date

01/02/1991

Overall trial end date

31/12/1994

Reason abandoned

Eligibility

Participant inclusion criteria

Histologically proven non-seminomatous germ cell tumour

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

154

Participant exclusion criteria

Previous radiotherapy or chemotherapy

Recruitment start date

01/02/1991

Recruitment end date

31/12/1994

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 (MRC) (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

Publication citations

Additional files

Editorial Notes