Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours
NCT ID: NCT01726374
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
246 participants
INTERVENTIONAL
2010-02-28
2024-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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One cycle adjuvant 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
BEP(500)
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
Interventions
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BEP(500)
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
MALE
No
Sponsors
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University Hospital Birmingham NHS Foundation Trust
OTHER
Cancer Research UK
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Professor Michael Cullen
Role: PRINCIPAL_INVESTIGATOR
University Hospital Birmingham NHS Foundation Trust
Locations
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Guy's Hospital
London, England, United Kingdom
Northampton General Hospital NHS Trust
Northampton, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, 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
Countries
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References
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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.
Other Identifiers
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ISRCTN37875250
Identifier Type: REGISTRY
Identifier Source: secondary_id
2008-006295-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
09/H1102/86
Identifier Type: OTHER
Identifier Source: secondary_id
CRUK/09/011
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ICR-CTSU/2008/10019
Identifier Type: -
Identifier Source: org_study_id