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Testicular cancer trial: could a stronger chemo course cut relapse risk?

NCT ID NCT02341989

Disease control Sponsor: St. Olavs Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether one course of BEP chemotherapy works better than one course of carboplatin to prevent seminoma testicular cancer from coming back after surgery. It includes 348 men with stage I seminoma who have risk factors like a large tumor or rete testis invasion. The study compares relapse rates and side effects between the two treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bleomycin, etoposide, and cisplatin (BEP) or carboplatin
What this could lead to
If BEP works better, it could offer a more effective single-course option to prevent seminoma from coming back after surgery.
What could go wrong
This is an early-phase comparison; BEP may cause more side effects than carboplatin, and the trial is not yet complete. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 348 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2015

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

neoplasm of testis Recurrence seminoma testicular cancer testicular seminoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Seminoma Testicular neoplasms

Contacts and locations

Locations

  • Institutt for kreftforskning og molekylær medisin, St Olavs Hospital

    Trondheim, Norway

  • St. Olavs University hospital HF

    Trondheim, Norway

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