Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours (111)

This study is currently recruiting participants.
Verified April 2013 by Institute of Cancer Research, United Kingdom
Sponsor:
Collaborators:
University Hospital Birmingham NHS Foundation Trust
Cancer Research UK
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01726374
First received: November 9, 2012
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Stage I Testicular Non-Seminomatous Germ Cell Tumor
Drug: BEP(500)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • Recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%


Secondary Outcome Measures:
  • Immediate and delayed toxicity including long-term permanent infertility (>2 years) [ Time Frame: 0 - > 2 years ] [ Designated as safety issue: Yes ]
  • Relapse free survival [ Time Frame: Patients followed up for 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Patients followed up for 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 236
Study Start Date: February 2010
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726374

Contacts
Contact: 111 Trial Manager 020 8772 4057 111-icrctsu@icr.ac.uk

Locations
United Kingdom
Guy's Hospital Recruiting
London, England, United Kingdom, SE1 9RT
Northampton General Hospital NHS Trust Recruiting
Northampton, England, United Kingdom, NN6 8BJ
Velindre Cancer Center at Velindre Hospital Recruiting
Cardiff, Wales, United Kingdom, CF14 2TL
Aberdeen Royal Infirmary Recruiting
Aberdeen, United Kingdom
Ysbyty Gwynedd Recruiting
Bangor, United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom
Royal Sussex County Hospital Recruiting
Brighton, United Kingdom
Bristol Haematology and Oncology Centre Recruiting
Bristol, United Kingdom
Queen's Hospital Recruiting
Burton-on-Trent, United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom
Gloucestershire Royal Hospital Recruiting
Cheltenham, United Kingdom
Cheltenham General Hospital Recruiting
Cheltenham, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust Recruiting
Coventry, United Kingdom
Royal Derby Hospital Recruiting
Derby, United Kingdom
Western General Hospital Recruiting
Edinburgh, United Kingdom
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom
Castle Hill Hospital Recruiting
Hull, United Kingdom
Ipswich Hospital Recruiting
Ipswich, United Kingdom
St James's University Hospital Recruiting
Leeds, United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Lincoln County Hospital Recruiting
Lincoln, United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
Clatterbridge Centre for Oncology Recruiting
Liverpool, United Kingdom
St Bartholomew's Hospital Recruiting
London, United Kingdom
University College Hospital Recruiting
London, United Kingdom
Maidstone Hospital Recruiting
Maidstone, United Kingdom
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom
Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom
Nottingham City Hospital Recruiting
Nottingham, United Kingdom
Churchill Hospital Recruiting
Oxford, United Kingdom
Weston Park Hospital Recruiting
Sheffield, United Kingdom
Southampton General Hospital Recruiting
Southampton, United Kingdom
Royal Marsden Hospital Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
University Hospital Birmingham NHS Foundation Trust
Cancer Research UK
Investigators
Principal Investigator: Professor Michael Cullen University Hospitals Birmingham NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01726374     History of Changes
Other Study ID Numbers: ICR-CTSU/2008/10019, ISRCTN37875250, 2008-006295-29, 09/H1102/86, CRUK/09/011
Study First Received: November 9, 2012
Last Updated: April 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014