Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
One course of adjuvant carboplatin AUC7 is considered internationally to be a standard
treatment option in clinical stage I seminoma, regardless of risk factors. Treatment is based
on a large, randomized phase III study comparing adjuvant carboplatin with adjuvant
radiotherapy. This study was done without registering data on possible risk factor for
relapse. The relapse rate following carboplatin was in this study estimated to be 5.3 %. Data
from a prospective, risk-adapted Spanish study showed that patients without risk factors had
a very low risk of relapse, even without adjuvant treatment. This result is also confirmed by
a recent analysis of SWENOTECA VII data, showing that this group of patients has a risk of
relapse of less than 5 % without adjuvant treatment.
Combined data from SWENOTECA V and VII studies indicate a high risk of relapse in patients
with one or two risk factors (tumor 4 cm, stromal invasion of rete testis) treated with one
course of adjuvant carboplatin. The relapse rate in this group of patients was 9.4 %,
indicating a very modest effect of one course of adjuvant carboplatin. If adjuvant
chemotherapy is the preferred treatment strategy, more potent chemotherapy regimens should be
explored in this patient group. The results from SWENOTECA III/VI studies with one course of
cisplatin-based adjuvant chemotherapy in clinical stage I nonseminoma, show a very low rate
of relapse. As seminoma is even more chemosensitive than nonseminoma the relapse rate
following one course of adjuvant BEP is expected to be very low, close to 1 %.
The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse
rate than one course of adjuvant carboplatin AUC7. In addition, it will be investigated if
there is a difference in health related quality of life as well as acute and long-term
toxicities from treatment.
Phase:
Phase 3
Details
Lead Sponsor:
St. Olavs Hospital
Collaborators:
Haukeland University Hospital Karolinska Institutet Norrlands University Hospital Oslo University Hospital Sahlgrenska University Hospital, Sweden Skane University Hospital University Hospital of North Norway University Hospital, Linkoeping Uppsala University Hospital