Stage I Testicular Non-Seminomatous Germ Cell Tumor Clinical Trial
— 111Official title:
A Single Group Trial Evaluating One Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Tumours of the Testis (NSGCTT)
| Verified date | April 2020 |
| Source | Institute of Cancer Research, United Kingdom |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 246 |
| Est. completion date | August 2020 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically proven non-seminomatous germ cell tumour of combined GCT (NSGCT + seminoma)of the testis - Histologically proven vascular invasion of the primary tumour into the testicular veins or lymphatics - Clinical stage 1 patients (normal AFP and HCG, or optimum marker decline approaching normal levels after orchidectomy AND no evidence of metastases on CT of chest, abdomen and pelvis) - Men aged 16 years or over - Creatinine clearance > 50 ml/min - No previous chemotherapy - WBC > 1.5 x 10^9/l and platelets 100 x 10^9/l - Fit to receive chemotherapy - Able to start BEP(500) chemotherapy as part of 111 study within 6* weeks of orchidectomy - Written informed consent *If there are unavoidable delays this timescale can be extended to 8 weeks Exclusion Criteria: - All patients with pure seminoma - All patients with non-seminoma or combined NSGCT + seminoma > stage 1 - All patients with no vascular invasion - Previous chemotherapy - Patients with second malignancy except contralateral TIN and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more than 3 years - Co-morbidity precluding the safe administration of BEP(500) chemotherapy - Patients with renal function impairment (bilirubin >1.25 x ULN and/or AST >2 x ULN) - Patients with pre-existing neuropathy - Patients with pulmonary fibrosis - Patients with serious illness or medical conditions incompatible with the protocol |
| Country | Name | City | State |
|---|---|---|---|
| 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 | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales |
| 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 | Guy's Hospital | London | England |
| 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 | Northampton General Hospital NHS Trust | Northampton | England |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Cancer Research, United Kingdom | Cancer Research UK, University Hospital Birmingham NHS Foundation Trust |
United Kingdom,
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, — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence | To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5% | 2 years | |
| Secondary | Immediate and delayed toxicity including long-term permanent infertility (>2 years) | 0 - > 2 years | ||
| Secondary | Relapse free survival | Patients followed up for 5 years | ||
| Secondary | Overall survival | Patients followed up for 5 years |