Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
03/08/2009
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

TE20

Study information

Scientific title

Acronym

Study hypothesis

To compare 3 x BEP and 3 x BEP + 1 x EP and the five day schedule versus three days per cycle in good prognosis germ cell cancer

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

Testicular cancer

Intervention

There are four groups:
1. The first receives three cycles of BEP chemotherapy over a five day schedule
2. The second group receives three cycles of BEP + 1 cycle of EP chemotherapy over a 5 day schedule
3. The third group receives three cycles of BEP over a 3 day schedule
4. The fourth group receives three cycles of BEP over a 3 day schedule plus one cycle of EP

Intervention type

Drug

Phase

Not Specified

Drug names

Several

Primary outcome measures

1. Time to progression
2. Quality of life
3. Morbidity
4. Survival time

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1995

Overall trial end date

01/05/1998

Reason abandoned

Eligibility

Participant inclusion criteria

1. Seminoma or non-seminoma - testis or retroperitoneal primary, alpha-fetoprotein (AFP) ≤1000 iu/l human chorionic gonadotrophin (HCG) ≤5000 iu/l, lactic dehydrogenase (LDH) ≤1.5 x N
2. No liver, bone or brain mets seminoma - stage ≥2 C or relapse after radiotherapy and any primary site and LDH
3. No liver bone or brain mets

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

800

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/1995

Recruitment end date

01/05/1998

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

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11250991
2. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12637478

Publication citations

  1. Results

    de Wit R, Roberts JT, Wilkinson PM, de Mulder PH, Mead GM, Fosså SD, Cook P, de Prijck L, Stenning S, Collette L, Equivalence of three or four cycles of bleomycin, etoposide, and cisplatin chemotherapy and of a 3- or 5-day schedule in good-prognosis germ cell cancer: a randomized study of the European Organization for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group and the Medical Research Council., J. Clin. Oncol., 2001, 19, 6, 1629-1640.

  2. Results

    Fosså SD, de Wit R, Roberts JT, Wilkinson PM, de Mulder PH, Mead GM, Cook P, de Prijck L, Stenning S, Aaronson NK, Bottomley A, Collette L, , , Quality of life in good prognosis patients with metastatic germ cell cancer: a prospective study of the European Organization for Research and Treatment of Cancer Genitourinary Group/Medical Research Council Testicular Cancer Study Group (30941/TE20)., J. Clin. Oncol., 2003, 21, 6, 1107-1118.

Additional files

Editorial Notes