Study of chemotherapy for patients with good prognosis metastatic non-seminomatous testicular cancer
| ISRCTN | ISRCTN79658966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79658966 |
| Protocol serial number | TE03 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 11/01/2019
- 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
Dr Pat Cook
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| Phone | +44 20 7670 4600 |
|---|---|
| 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 of chemotherapy for patients with good prognosis metastatic non-seminomatous testicular cancer |
| Study objectives | Investigate whether the toxicity of chemotherapy in patients with small volume metastasis and low blood marker concentrations can be decreased by the reduction of the dose of Bleomycin given in the BEP regimen without loss of therapeutic activity. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | Arm 1: Bleomycin 30 mg x 3 per course, BEP x 4 Arm 2: Bleomycin 30 mg per course, BEP x 4 |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Bleomycin, etoposide, cisplatin (platinum) |
| Primary outcome measure(s) |
Toxicity/response |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1986 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 44 |
| Key inclusion criteria | Histologically proven non-seminomatous testicular cancer |
| Key exclusion criteria | Previous radiotherapy or chemotherapy |
| Date of first enrolment | 01/01/1986 |
| Date of final enrolment | 31/12/1986 |
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
11/01/2019: No publications found. All search options exhausted.
29/03/2018: Verifying publication status with principal investigator.
