International Study for the Salvage Treatment of Germ Cell Tumours
| ISRCTN | ISRCTN11143611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11143611 |
| Secondary identifying numbers | GE301 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 11/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 15/01/1994 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- France
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Institut Gustave-Roussy (France)
Research organisation
Research organisation
39 rue Camille Desmoullins
Villejuif Cedex
94805
France
| Phone | +33 (0) 1 42114211 |
|---|---|
| roussy@igr.fr | |
| Website | http://www.igr.fr |
"ROR" |
https://ror.org/0321g0743 |
Funders
Funder type
Research organisation
Institut Gustave-Roussy (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
