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Can some seminoma patients safely skip heavier treatment?

NCT ID NCT05529251

Disease control Sponsor: Centre Leon Berard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

This phase 2 trial explores whether some people with stage II seminoma, a type of testicular cancer, can receive less intensive treatment after surgery. All participants first receive one cycle of EP chemotherapy. Those whose PET scan is negative are then randomly assigned to either a targeted radiotherapy boost or one cycle of carboplatin. Those with a positive PET scan receive three more cycles of EP. The study also tracks blood levels of a marker called miRNA-M371 to see if it can predict how well the cancer responds.

What this could mean

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

Active substance
Radiotherapy boost, carboplatin, and etoposide plus cisplatin (EP) chemotherapy
What this could lead to
If the approach works, some people with early-stage seminoma could avoid more intensive treatment while keeping their cancer under control. The blood marker miRNA-M371 might also help doctors predict who responds best.
What could go wrong
The trial is small and early-stage, so the results may not apply to everyone. Reducing treatment could raise the risk that the cancer comes back, and the miRNA marker may not prove reliable enough to guide decisions.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

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

Started

Sep 2022

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 years and older

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 : 1. Age ≥ 18 years on the day of signing informed consent. 2. Primary testicular seminomatous germ cell tumor. 3. Stage IIa/IIb \< 3 cm in largest diameter seminoma, histologically proved after orchiectomy. 4. Confirmation of a progressive disease (positive PET scan or increase of lymph nodes size by two successive CT scan). 5. Good prognosis according to IGCCCG and LDH \< 2.5 x Upper Limit of Normal (ULN). 6. Normal alpha-fetoprotein (AFP) before and after orchiectomy. 7. No prior treatment with radiotherapy or chemotherapy. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2. 9. Adequate bone-marrow, hepatic, and renal functions with: * Neutrophils ≥ 1.5 x Giga/l, platelets ≥ 100 x Giga/l, * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1,5 x ULN, * Serum creatinine \< 140 µmol/l OR calculated clearance \> 60 ml/min (using either Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) for \> 65 years old), * Total bilirubin ≤ ULN (if \> ULN, direct bilirubin ≤ ULN). 10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 11. Accepting to use effective contraceptive measures or abstain from heterosexual activity, for the course of the study and through 12 months after the last dose of chemotherapy or being surgically sterile. All patients should seek advice regarding cryoconservation of sperm prior treatment initiation because of the possibility of infertility 12. Affiliation to a health insurance. 13. Signed and dated informed consent. Non-exclusion criteria : 1. Extra-retroperitoneal metastasis on Computed tomography scan (CT scan). 2. Infection by Human Immunodeficiency Virus (HIV), or active infection with the Hepatitis B or C virus. 3. History, within 2 years, of cancer other than seminoma, except for treated skin cancer (basal cell). 4. Uncontrolled or severe cardiovascular pathology. 5. Uncontrolled or severe hepatic pathology. 6. Patient deprived of liberty or requiring tutorship or curatorship. 7. Psychological, physical, sociological, or geographical conditions that would limit compliance with study protocol requirements (at the investigator's discretion). 8. Participation to another clinical trial, except for supportive care trials.

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Conditions

The condition(s) this trial relates to.

seminoma testicular seminoma

As listed by the trial registrant

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

Seminoma Stage II

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Besançon

    RECRUITING

    Besançon, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, France

  • CHU de Limoges

    RECRUITING

    Limoges, France

  • Centre Antoine Lacassagne

    ACTIVE_NOT_RECRUITING

    Nice, France

  • Centre François Baclesse

    RECRUITING

    Caen, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, France

  • Centre Leon Bérard

    RECRUITING

    Lyon, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, France

  • Hôpital Foch

    NOT_YET_RECRUITING

    Suresnes, France

  • Hôpital Saint Louis

    NOT_YET_RECRUITING

    Paris, France

  • ICO René Gauducheau

    RECRUITING

    Saint-Herblain, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, France

  • Institut Universitaire de Cancer de Toulouse (IUCT-O)

    RECRUITING

    Toulouse, France

  • Institut de Cancérologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, France

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