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Clinical Trial 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 Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Neoplasms, Germ Cell and Embryonal
  • Stage I Testicular Non-Seminomatous Germ Cell Tumor
  • Testicular Neoplasms

NCT number NCT01726374
Study type Interventional
Source Institute of Cancer Research, United Kingdom
Contact
Status Active, not recruiting
Phase Phase 3
Start date February 2010
Completion date August 2020