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Completed

NCT Number: NCT01726374

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

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.

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Key information

Conditions

Stage I Testicular Non-Seminomatous Germ Cell Tumor

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Guy's Hospital, London, England, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Recurrence

    Time frame: 2 years

    To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%

Secondary outcomes

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

    Time frame: 0 - > 2 years

  2. Relapse free survival

    Time frame: Patients followed up for 5 years

  3. Overall survival

    Time frame: Patients followed up for 5 years

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Cancer Research UK
  • University Hospital Birmingham NHS Foundation Trust

Registry information

Official study 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)

Acronym: 111

Important dates

Study start
2010
Primary completion
2016
Study completion
2024
First posted
Nov 14, 2012
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.