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

NCT02341989 | Active Not Recruiting Phase 3

• 2 other identifiers: 2014/20122014-004075-23
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Chemotherapy, adjuvant; Recurrence; Carboplatin; Bleomycin; Etoposide; Cisplatin

Outcome Measures

Primary Outcomes (1)

• Relapse rate

  10 years

Study Arms (2)

Bleomycin-Etoposide-Cisplatin

EXPERIMENTAL

One course of adjuvant BEP.

Drug: Bleomycin Etoposide and Cisplatin

Carboplatin

ACTIVE COMPARATOR

One course of adjuvant carboplatin AUC7

Drug: Carboplatin

Interventions

Bleomycin Etoposide and Cisplatin DRUG

Also known as: BEP

Bleomycin-Etoposide-Cisplatin

Carboplatin DRUG

Also known as: Carboplatin AUC7

Carboplatin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and invasion of the rete testis
• Clinical stage I
• Tumor size over 4 cm and/or stromal invasion of the rete testis by tumor cells
• Normal value of alpha-fetoprotein (AFP) before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted.
• Age ≥ 18 years and \< 60 years
• Adequate organ function defined as:
• Serum aspartate transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Creatinine clearance \> 50 ml/min (eGFR) All fertile patients should use safe contraception Written informed consent

You may not qualify if:

• Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis. Patients in need of restaging (see SWENOTECA IX) should not be included
• Prior diagnosis of testicular cancer
• Chronic pulmonary disorders giving a high risk of bleomycin induced toxicity (for example chronic obstructive pulmonary disease or lung fibrosis)
• Cancer other than seminoma testicular cancer
• Known hypersensitivity or contraindications for the study drugs
• Serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
• Medical, social, psychological conditions that could prevent adequate information and follow-up

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Haukeland University Hospital: collaborator
• University Hospital of North Norway: collaborator
• Sahlgrenska University Hospital: collaborator
• Karolinska Institutet: collaborator
• Oslo University Hospital: collaborator
• Uppsala University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Skane University Hospital: collaborator
• Norrlands University Hospital: collaborator

Study Sites (2)

Institutt for kreftforskning og molekylær medisin, St Olavs Hospital

Trondheim, Norway

Location

St. Olavs University hospital HF

Trondheim, Norway

Location

MeSH Terms

Conditions

Testicular Neoplasms; Seminoma; Recurrence

Interventions

Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Olof Ståhl, Md PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

• Torgrim Tandstad, MD PhD

  St. Olavs University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 19, 2015
• Study Start: April 8, 2015
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2032
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

NO (2)