Clinical Trial: Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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)
Brief 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.
Detailed Summary:
Sponsor: Institute of Cancer Research, United Kingdom
Current Primary Outcome: Recurrence [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Institute of Cancer Research, United Kingdom
Dates:
Date Received: November 9, 2012
Date Started: February 2010
Date Completion: August 2019
Last Updated: September 18, 2015
Last Verified: September 2015
