Randomised phase II trial comparing intensive induction chemotherapy (CBOP BEP) with standard BEP chemotherapy in poor prognosis male germ cell tumours
| ISRCTN | ISRCTN53643604 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53643604 |
| ClinicalTrials.gov (NCT) | NCT00301782 |
| Clinical Trials Information System (CTIS) | 2004-000405-22 |
| Protocol serial number | MRC TE23 Study, Version 1.0 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) |
- Submission date
- 11/08/2004
- Registration date
- 22/10/2004
- Last edited
- 25/10/2022
- 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
Contact information
Dr Robert Huddart
Scientific
Scientific
Institute of Cancer Research and Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | - |
| Study acronym | TE23 |
| Study objectives | Not provided at time of registration More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=38 |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Male non-seminoma germ cell tumours (NSGCT) |
| Intervention | Patients will be randomly allocated either the 'gold standard' BEP (bleomycin, etoposide and cisplatin) chemotherapy or the intensive induction regimen CBOP/BEP (carboplatin, bleomycin, vincristine, cisplatin, etoposide). |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Bleomycin, carboplatin, cisplatin, etoposide phosphate, vincristine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target sample size at registration | 88 |
| Total final enrolment | 89 |
| Key inclusion criteria | 1. Non-seminomatous germ cell tumour of any extracranial primary site 2. Poor prognosis features, as defined by the International Germ Cell Cancer Collaborative Group (IGCCCG) criteria 3. Performance status 0 - 3 4. Globular filtration rate greater than 50 ml/min 5. No comorbid condition |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Cancer Research and Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom
SM2 5PT
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 01/03/2020 | 03/02/2020 | Yes | No |
| Plain English results | 25/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
03/02/2020: Publication reference added.
