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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
246
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
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
Recurrence
To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%
Time frame: 2 years
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
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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
...and 25 more locations