Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer

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.

Conditions

• Testicular Neoplasms
• Seminoma

Interventions

DRUG

Bleomycin Etoposide and Cisplatin

DRUG

Carboplatin

Sponsors & Collaborators

• Haukeland University Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• University Hospital, Linkoeping

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Norrlands University Hospital

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Olof Ståhl, Md PhD · Skane University Hospital

• Torgrim Tandstad, MD PhD · St. Olavs University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-08

Primary Completion

2027-05-31

Completion

2032-05-31

Countries

• Norway

Study Locations