Treatment of high risk testicular tumour with high dose chemotherapy with peripheral blood stem cells
| ISRCTN | ISRCTN85255912 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85255912 |
| Secondary identifying numbers | N0063044257 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 1. Time to white cell and platelet recovery 2. Confirmation of response 3. Assessment of toxicity by standard World Health Organisation (WHO) grades |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/1994 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Clinical Oncology
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Christie Hospital NHS Trust (UK)
No information available
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 |
Editorial Notes
20/04/2016: No publications found, verifying study status with principal investigator.
