Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
11/07/2014
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

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GE301

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Testis

Intervention

1. Group A: Chemotherapy with etoposide, ifosfamide, mensa and CDDP (PEI) or etoposide, ifosfamide, mensa and CDDP (VEIP). Treatment cycle repeated every 21 days for four cycles.
2. Group B: Chemotherapy with PEI or VEIP. Treatment cycle repeated every 21 days for three cycles followed by myeloablative chemotherapy with carboplatin, etoposide, cyclophosphamide and mensa (CarboPec) plus ABMT/PBSC.

Intervention type

Drug

Phase

Not Specified

Drug names

Cancer drugs

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/01/1994

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males aged >16 years
2. Germ cell tumours, either testicular or extragonadal
3. Platinum combination chemotherapy as first line chemotherapy
4. Remission after complete response from first line chemotherapy
5. Partial responder patients after first line chemotherapy, including patients with resection of viable malignancy after first line chemotherapy with elevated tumour markers
6. World Health Organisation (WHO) performance status grade 0-2
7. Seminoma patients relapsing after complete response after cisplatin-based chemotherapy or partial response under cisplatin-based chemotherapy
8. Refactory patients are to be excluded
9. Patients with pure seminoma treated with carboplatin are excluded
10. No other malignancy
11. No medical contraindications to protocol treatments

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

15/01/1994

Recruitment end date

31/12/2004

Locations

Countries of recruitment

France

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Institut Gustave-Roussy (France)

Sponsor details

39 rue Camille Desmoullins
Villejuif Cedex
94805
France
+33 (0) 1 42114211
roussy@igr.fr

Sponsor type

Research organisation

Website

http://www.igr.fr

Funders

Funder type

Research organisation

Funder name

Institut Gustave-Roussy (France)

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

Publication citations

Additional files

Editorial Notes