Treatment of good prognosis germ cell cancer
| ISRCTN | ISRCTN35399995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35399995 |
| Secondary identifying numbers | TE20 |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 03/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Pat Cook
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| pat.cook@ctu.mrc.ac.uk |
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 | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Several |
| Primary outcome measure | 1. Time to progression 2. Quality of life 3. Morbidity 4. Survival time |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/1995 |
| Completion date | 01/05/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | 800 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/1995 |
| Date of final enrolment | 01/05/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/03/2001 | Yes | No | |
| Results article | results | 15/03/2003 | Yes | No |
