Treatment of high risk testicular tumour with high dose chemotherapy with peripheral blood stem cells
| ISRCTN | ISRCTN85255912 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85255912 |
| Protocol serial number | N0063044257 |
| Sponsor | Department of Health (UK) |
| Funder | Christie Hospital NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 20/04/2016
- 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 PM Wilkinson
Scientific
Scientific
Clinical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
| Phone | +44 0161 446 3261 |
|---|---|
| Peter.Wilkinson@christie-tr.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Treatment of high risk testicular tumour with high dose chemotherapy with peripheral blood stem cells |
| Study objectives | To assess the efficacy of high dose chemotherapy with peripheral blood stem cells to see if the response rate is improved compared to conventional therapy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Testicular |
| Intervention | High dose chemotherapy with peripheral blood stem cells vs no high dose |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Time to white cell and platelet recovery |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target sample size at registration | 6 |
| Key inclusion criteria | 1. Patients with histological proven non-seminomatous germ cell tumours 2. High risk factors as defined by MRC prognostic group |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/1994 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clinical Oncology
Manchester
M20 4BX
United Kingdom
M20 4BX
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/04/2016: No publications found, verifying study status with principal investigator.
