Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN37875250 | Registry Identifier | ISRCTN | |
| 2008-006295-29 | EudraCT Number | ||
| 09/H1102/86 | Other Identifier | Main REC | |
| CRUK/09/011 | Other Grant/Funding Number | CRUK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Birmingham NHS Foundation Trust | OTHER |
| Cancer Research UK | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis.
If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One cycle adjuvant BEP(500) | Experimental | Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEP(500) | Drug | One cycle of BEP(500): Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5% | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate and delayed toxicity including long-term permanent infertility (>2 years) | 0 - > 2 years | |
| Relapse free survival | Patients followed up for 5 years | |
| Overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Professor Michael Cullen | University Hospital Birmingham NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's Hospital | London | England | SE1 9RT | United Kingdom | ||
| Northampton General Hospital NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31901440 | Result | Cullen M, Huddart R, Joffe J, Gardiner D, Maynard L, Hutton P, Mazhar D, Shamash J, Wheater M, White J, Goubar A, Porta N, Witts S, Lewis R, Hall E; 111 Trial Management Group. The 111 Study: A Single-arm, Phase 3 Trial Evaluating One Cycle of Bleomycin, Etoposide, and Cisplatin as Adjuvant Chemotherapy in High-risk, Stage 1 Nonseminomatous or Combined Germ Cell Tumours of the Testis. Eur Urol. 2020 Mar;77(3):344-351. doi: 10.1016/j.eururo.2019.11.022. Epub 2020 Jan 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Patients followed up for 5 years |
| Northampton |
| England |
| NN6 8BJ |
| United Kingdom |
| Velindre Cancer Center at Velindre Hospital | Cardiff | Wales | CF14 2TL | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | United Kingdom |
| Ysbyty Gwynedd | Bangor | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | United Kingdom |
| Royal Sussex County Hospital | Brighton | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | United Kingdom |
| Queen's Hospital | Burton-on-Trent | United Kingdom |
| Addenbrooke's Hospital | Cambridge | United Kingdom |
| Cheltenham General Hospital | Cheltenham | United Kingdom |
| Gloucestershire Royal Hospital | Cheltenham | United Kingdom |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | United Kingdom |
| Royal Derby Hospital | Derby | United Kingdom |
| Western General Hospital | Edinburgh | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom |
| Royal Surrey County Hospital | Guildford | United Kingdom |
| Castle Hill Hospital | Hull | United Kingdom |
| Ipswich Hospital | Ipswich | United Kingdom |
| St James's University Hospital | Leeds | United Kingdom |
| Leicester Royal Infirmary | Leicester | United Kingdom |
| Lincoln County Hospital | Lincoln | United Kingdom |
| Clatterbridge Centre for Oncology | Liverpool | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | United Kingdom |
| St Bartholomew's Hospital | London | United Kingdom |
| University College Hospital | London | United Kingdom |
| Maidstone Hospital | Maidstone | United Kingdom |
| James Cook University Hospital | Middlesbrough | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | United Kingdom |
| Nottingham City Hospital | Nottingham | United Kingdom |
| Churchill Hospital | Oxford | United Kingdom |
| Weston Park Hospital | Sheffield | United Kingdom |
| Southampton General Hospital | Southampton | United Kingdom |
| Royal Marsden Hospital | Sutton | United Kingdom |