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A randomized study in testicular cancer without metastasis, comparing two different types of chemotherapy used to reduce the risk of relapse
EU CTIS ID: 2024-518399-29-00
What this study is testing
The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse rate compared to one course of adjuvant carboplatin AUC7.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and stromal 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 AFP before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted
- Age ≥ 18 years and < 60 years
- ECOG performance status 0, 1 or 2
You likely can't join if
- Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis
- 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)
- Prior history of any cancer the last 5 years excluding basal cell carcinoma
- 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
See the full eligibility criteria
- Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and stromal 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 AFP before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted
- Age ≥ 18 years and < 60 years
- ECOG performance status 0, 1 or 2
- Adequate organ function defined as: a. Serum alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). b. Total serum bilirubin ≤ 1.5 x ULN c. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L d. Platelets ≥ 100 x 109/L e. GFR > 50 ml/min (see below for allowed methods of analysis)
- All fertile patients should use safe contraception 6 months following adjuvant treatment (Patient: Condom (Sweden only) or sterilisation or Partner: combination hormonal contraceptive, sterilisation or intrauterine device)
- Written informed consent
- Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis
- 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)
- Prior history of any cancer the last 5 years excluding basal cell carcinoma
- 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
- Conditions – medical, social, psychological – which could prevent adequate information and follow-up
- Medication interacting with the study drugs
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.