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Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours

Information source: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage I Testicular Non-Seminomatous Germ Cell Tumor

Intervention: BEP(500) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Institute of Cancer Research, United Kingdom

Official(s) and/or principal investigator(s):
Professor Michael Cullen, Principal Investigator, Affiliation: University Hospitals Birmingham NHS Foundation Trust

Summary

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.

Clinical Details

Official 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)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Recurrence

Secondary outcome:

Immediate and delayed toxicity including long-term permanent infertility (>2 years)

Relapse free survival

Overall survival

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Locations and Contacts

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

Guy's Hospital, London, England SE1 9RT, United Kingdom

Northampton General Hospital NHS Trust, Northampton, England NN6 8BJ, United Kingdom

Velindre Cancer Center at Velindre Hospital, Cardiff, Wales CF14 2TL, United Kingdom

Additional Information

Starting date: February 2010
Last updated: September 8, 2014

Page last updated: August 20, 2015

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