Treatment of poor prognosis metastatic teratoma
| ISRCTN | ISRCTN14535482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14535482 |
| Protocol serial number | TE13 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 29/10/2019
- 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
Miss Sharon Naylor
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Treatment of poor prognosis metastatic teratoma |
| Study objectives | Determine whether treatment with the intensive regimen BOP/VIP-B is more effective than BEP/P. To determine the effect of G-CSF on the proportion of patients receiving full dose intensity of combination chemotherapy with either regimen. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Metastatic teratoma |
| Intervention | Arm 1 - Without granulocyte colony stimulating factor (G-CSF), BEP/EP. Arm 2 - Without G-CSF, BOP/VIP-B. Arm 3 - With G-CSF, BEP/EP. Arm 4 - With G-CSF, BOP/VIP-B. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Several |
| Primary outcome measure(s) |
Progression-free survival |
| Key secondary outcome measure(s) |
Response rate, overall survival |
| Completion date | 31/12/1994 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 154 |
| Key inclusion criteria | Histologically proven non-seminomatous germ cell tumour |
| Key exclusion criteria | Previous radiotherapy or chemotherapy |
| Date of first enrolment | 01/02/1991 |
| Date of final enrolment | 31/12/1994 |
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 |
Editorial Notes
29/10/2019: No publications found. All search options exhausted.
