Overview

This trial is active, not recruiting.

Condition stage i testicular non-seminomatous germ cell tumor
Treatment bep(500)
Phase phase 3
Sponsor Institute of Cancer Research, United Kingdom
Collaborator University Hospital Birmingham NHS Foundation Trust
Start date February 2010
End date August 2016
Trial size 236 participants
Trial identifier NCT01726374, 09/H1102/86, 2008-006295-29, CRUK/09/011, ICR-CTSU/2008/10019, ISRCTN37875250

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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

Primary Outcomes

Measure
Recurrence
time frame: 2 years

Secondary Outcomes

Measure
Immediate and delayed toxicity including long-term permanent infertility (>2 years)
time frame: 0 - > 2 years
Relapse free survival
time frame: Patients followed up for 5 years
Overall survival
time frame: Patients followed up for 5 years

Eligibility Criteria

Male participants at least 16 years old.

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

Additional Information

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)
Principal investigator Professor Michael Cullen
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Institute of Cancer Research, United Kingdom.