Study of carboplatin based combination chemotherapy for good prognosis metastatic malignant teratoma
| ISRCTN | ISRCTN69711558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69711558 |
| Protocol serial number | TE09 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 11/09/2007
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To define equivalent activity and lower toxicity of combination chemotherapy containing carboplatin rather than cisplatin |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | Arm 1 - 4 cycles BEP. Arm 2 - 4 cycles CEB. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Carboplatin |
| Primary outcome measure(s) |
Complete remission on chemotherapy or chemotherapy + surgery. Progression-free survival. Survival, toxicity. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 450 |
| Key inclusion criteria | Histologically confirmed non-seminomatous germ cell tumour of testis or combined seminoma/teratoma or seminoma with unequivocal raised serum alpha feto protein concentration |
| Key exclusion criteria | Previous chemotherapy. |
| Date of first enrolment | 01/06/1989 |
| Date of final enrolment | 31/12/1993 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/05/1997 | Yes | No |
