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SeminomaPhase 2EDENNCT05529251

De-escalation Study for Stage IIa/IIb < 3 cm Seminoma

A Phase 2 study testing Radiotherapy boost, Carboplatin AUC7 and 3 cycles of EP in people with Seminoma and Stage II, run by Centre Leon Berard at 15 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Phase II, multicenter, prospective, randomized, non-comparative, de-escalation study. Patients with stage IIa/IIb < 3 cm seminoma histologically proved after orchiectomy will be included in the study and will receive 1 cycle of Etoposide Cisplatine (EP) chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Seminoma, Stage II
What is being tested?
Radiotherapy boost, Carboplatin AUC7 and 3 cycles of EP
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
15 sitesFrance
Study dates
6 Sep 2022to 4 May 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years on the day of signing informed consent.
  • Primary testicular seminomatous germ cell tumor.
  • Stage IIa/IIb < 3 cm in largest diameter seminoma, histologically proved after orchiectomy.
  • Confirmation of a progressive disease (positive PET scan or increase of lymph nodes size by two successive CT scan).
  • Good prognosis according to IGCCCG and LDH < 2.5 x Upper Limit of Normal (ULN).
  • Normal alpha-fetoprotein (AFP) before and after orchiectomy.
Show all 26Show fewer
  • No prior treatment with radiotherapy or chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
  • 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).
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • 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
  • Affiliation to a health insurance.
  • Signed and dated informed consent.
  • Non-exclusion criteria :
  • Extra-retroperitoneal metastasis on Computed tomography scan (CT scan).
  • Infection by Human Immunodeficiency Virus (HIV), or active infection with the Hepatitis B or C virus.
  • History, within 2 years, of cancer other than seminoma, except for treated skin cancer (basal cell).
  • Uncontrolled or severe cardiovascular pathology.
  • Uncontrolled or severe hepatic pathology.
  • Patient deprived of liberty or requiring tutorship or curatorship.
  • Psychological, physical, sociological, or geographical conditions that would limit compliance with study protocol requirements (at the investigator's discretion).
  • Participation to another clinical trial, except for supportive care trials.

Who cannot join

None listed.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ellen BLANC contact

+33 4 78 78 29 67

ellen.blanc@lyon.unicancer.fr

Aude FLECHON, Dr contact

+ 33 4 78 78 26 43

aude.flechon@lyon.unicancer.fr

15 sites in 1 country

France15 sites, 14 recruiting

  • CHU Besançon

    Besançon

    Elodie KLAJER, elodie.klajer@gmail.com

    Recruiting

  • CHU Bordeaux

    Bordeaux

    Marine GROSS-GOUPIL, marine.gross-goupil@chu-bordeaux.fr

    Recruiting

  • Centre François Baclesse

    Caen

    Florence JOLY, f.joly@baclesse.unicancer.fr

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Hakim MAHAMMEDI, hakim.mahammedi@clermont.unicancer.fr

    Recruiting

  • Centre Oscar Lambret

    Lille

    Thomas RYCKEWAERT, t-ryckewaert@o-lambret.fr

    Aurélien CARNOT

    Recruiting

  • CHU de Limoges

    Limoges

    Julia PESTRE MUNIER, julia.munier-pestre@chu-limoges.fr

    Valérie LE BRUN-LY

    Recruiting

  • Centre Leon Bérard

    Lyon

    Aude FLECHON, aude.flechon@lyon.unicancer.fr

    Armelle VINCENEUX

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Gwenaëlle GRAVIS, gravisg@ipc.unicancer.fr

    Slimane DERMECHE

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Active, not recruiting

  • Hôpital Saint Louis

    Paris

    Stéphane CULINE, stephane.culine@sls.aphp.fr

    Clément DUMONT

    Not yet recruiting

  • ICO René Gauducheau

    Saint-Herblain

    Emmanuelle BOMPAS, emmanuelle.bompas@ico.unicancer.fr

    Frédéric ROLLAND

    Recruiting

  • Hôpital Foch

    Suresnes

    Christine ABRAHAM, c.abraham@hopital-foch.com

    Not yet recruiting

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

    Toulouse

    Loïc MOUREY, mourey.loic@iuct-oncopole.fr

    Thibaud VALENTIN

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

    Lionel GEOFFROIS, l.geoffrois@nancy.unicancer.fr

    Camille SIMON

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Pierre BLANCHARD, pierre.blanchard@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: Prospective Therapeutic De-escalation and miRNA-M371 Biomarker Evaluation Phase II Study for Stage IIa/IIb < 3 cm Seminomas

Phase II, multicenter, prospective, randomized, non-comparative, de-escalation study.

Patients with stage IIa/IIb < 3 cm seminoma histologically proved after orchiectomy will be included in the study and will receive 1 cycle of Etoposide Cisplatine (EP) chemotherapy.

Read more

Patients with negative week-3 PET-scan after the EP cycle, will be randomized (1:1 ratio, stratification according to the disease stage (stage IIa versus IIb seminoma)) to receive either radiotherapy (RT) boost on lymph nodes or 1 cycle of carboplatin AUC7 chemotherapy.

Patients with positive week-3 PET-scan will received 3 additional cycles of EP chemotherapy.

In parallel, eligible patients scheduled to receive standard lombo-aortic RT will be registered in an observational cohort.

Read the detailed description

Stage II seminoma is defined by the presence of retroperitoneal lymph node metastases. It concerns approximately 15% of patients with seminoma. The standard treatment for patients with stage IIa/b seminoma, after orchiectomy, is extended lumbo-aortic/ipsilateral iliac radiotherapy (RT). Performing chemotherapy (CT) with 3 courses of Bleomycin-Etoposide-Cisplatin (BEP) or 4 courses of Etoposide-Cisplatin (EP) is an alternative.

The optimal treatment choice remains controversial. Both treatment modalities are associated with excellent efficacy but also acute and late toxicities. European Society of Medical Oncology (ESMO) guidelines recommended in equal measure CT and RT for stage IIa. A recent systematic review concluded that RT and cisplatin-based combination CT are equally effective in clinical stage IIa/IIb seminoma, with a trend in favor of chemotherapy in stage IIb because of lower relapse rate. However, due to the rarity of stage II seminoma, a sufficiently powered randomized trial comparing radiotherapy with chemotherapy is unlikely to be completed.

De-escalation strategies are required to minimize acute and long-term toxicities while maintaining efficacy. De-escalated treatment for seminoma patients with stage IIb/IIC/III and good prognosis according to International Germ Cell Cancer Collaborative Group (IGCCCG), based on negative PET after 2 cycles of EP chemotherapy, is feasible and safe according to SEMITEP results (cohort 2). In case of negative PET, 1 additional cycle of CT with carboplatin AUC7 was administered.

Furthermore, serum levels of microRNA (miR)-371a-3p (miRNA-M371) have been significantly associated with clinical stage, primary tumor size and response to treatment in testicular germ cell tumors, with sensitivity and specificity higher than those of classic markers (hCGt, LDH). However, further evaluations are needed before modifying clinical practices.

We propose to conduct a multicenter, prospective, randomized, non-comparative, de-escalation phase II study in patients with stage IIa/IIb seminoma < 3 cm, evaluating:

  • a more de-escalated CT treatment: 1 cycle of EP followed, in case of negative PET, by either a boost of RT on lymph node or 1 cycle of carboplatin AUC7
  • the biomarker miRNA-M371 in therapeutic decision and correlation with PET.

In parallel, eligible patients scheduled to receive standard lombo-aortic RT will be registered in an observational cohort.

Conditions
Seminoma, Stage II
Being tested
Radiotherapy boost, Carboplatin AUC7, 3 cycles of EP
Keywords
De-escalation, Chemotherapy, Radiotherapy, Carboplatin, Etoposide, Cisplatine, Micro-RNA-M371, PET scan, Overall survival, Biomarker, Efficacy, Progression free rate, Safety, Quality of life
Medical subject headings
Seminoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy boostRadiation

    Radiotherapy boost 20 to 30 Gy, in daily 2 Gy fractions and 5 fractions per week :

    • 20 Gy if no more disease is visible (node < 1 cm in large diameter)
    • 24 Gy for nodes <= 2 cm
    • 30 Gy for nodes > 2 cm

  • Carboplatin AUC7Drug

    Carboplatin at dose (mg) = AUC7 (mg/ml x min) x (DFG ml/min + 25)

  • 3 cycles of EPDrug

    3 Cycles of EP chemotherapy, administred every 3 weeks following standard practice

Study groups in NCT05529251
Study groupRoleWhat they receive
ARM AExperimentalRADIOTHERAPY boost 20 to 30 Gy on lymph nodes
Receives: Radiation: Radiotherapy boost
ARM BExperimentalOne cycle of CARBOPLATIN AUC7
Receives: Drug: Carboplatin AUC7
ARM COther3 cycles of ETOPOSIDE and CISPLATIN
Receives: Drug: 3 cycles of EP
OBSERVATIONAL COHORTNo interventionSTANDARD RADIOTHERAPY on lymph nodes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFR-36M

    Progression-free rate at 36 months

    The PFR-36M is assumed to be a random variable following a binomial distribution Bin (n, p) where n is the sample size and p is the true underlying PFR-36M. Conclusions and inferences will be conducted on p. The prior distribution of p (representing the knowledge of the progression-free rate probability prior to observing the data) will be pre-specified. In the absence of a strong idea about the PFR-36M to be observed, a non-informative prior distribution Beta (1,1) will be considered.

    Pr[PFR-36M ≥ 80%] will be expressed in each arm, associated with its 95% credibility interval. A treatment arm will be considered a positive sign for efficacy of de-escalation if there is a high probability that PFR-36M will be higher or equal to 80%: Pr[PFR-36M ≥ 80%] ≥ 90%. It means that if most of the distribution (90% of it) falls to the right hand side of 80%, it indicates that it is very likely that the effect is at least 80%

    Measured: Up to 36 months after inclusion

Secondary outcomes (5)

  1. miRNA-M371

    Serum level of miRNA-M371 as a potential biomarker of response. Association between serum level of miRNA M371 and response to treatments (according to RECIST v1.1) will be evaluated using a non-parametric Wilcoxon Mann and Whitney test and describe with boxplots.

    Measured: Up to 5 years

  2. Association of PET scan results and miRNA-M371 rate

    Correlation between serum level of miRNA M371 and FDG-PET results (metabolic response) will be evaluated using the Kendall rank correlation and describe graphically.

    Measured: Up to 5 years

  3. Overall survival (OS)

    The Overall Survival will be defined as the time from date of inclusion to the date of death, from any cause. Patient whose death is not known at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

    The Kaplan-Meier (KM) approach will be used to estimate median OS. Median OS as well as Survival rates at specific timepoints will be presented together with their 95% confidence interval (CI).

    Measured: Up to 3 years

  4. Quality of life (QoL)

    The QoL will be assessed using the EORTC QLQ-C30 questionnaire.

    Measured: Up to 20 months

  5. Tolerance to treatment

    The tolerance to each treatment will be described mainly on the frequency of adverse events (AEs) and their intensity and severity determined using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 5. Descriptive statistics will be provided for characterizing and assessing patient tolerance to treatment.

    AEs will be described and coded, in total and per System Organ Class and Preferred Term with Medical Dictionary for Regulatory Activities (MedDRA) coding

    Measured: Up 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2022
  2. Study start6 Sep 2022
  3. Primary completion4 May 2032 (estimated)
  4. Study completion4 May 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
* In case of negative week-3 (after 1 EP cyle) PET-scan: Randomization according to 2 arms 1. Boost of radiotherapy 20 to 30 Gray (Gy) (ARM A) 2. Carboplatin AUC7 chemotherapy (ARM B) * In case of positive week-3 PET-scan: 3 courses of EP chemotherapy (ARM C) Parallel observational cohort for patients scheduled to receive standard lumbo-aortic radiotherapy after orchiectomy
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05529251
Sponsor's protocol ID
EDEN (ET21-344)
Acronym
EDEN
Status last verified
Sep 2026
First submitted
26 Aug 2022
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy boost, Carboplatin AUC7 and 3 cycles of EP in people with Seminoma and Stage II, run by Centre Leon Berard at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ellen BLANC (+33 4 78 78 29 67, ellen.blanc@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFR-36M (time frame: Up to 36 months after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05529251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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