Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
GE301
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Cancer drugs
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
15/01/1994
Overall study end date
31/12/2004
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, France, United Kingdom
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|