De-escalation treatment for early-stage seminoma

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

This study is testing whether giving less treatment after surgery for early-stage seminoma can still be effective while reducing side effects for patients.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Centre Leon Berard (other)
• Drugs / interventions: chemotherapy
• Locations: 15 sites (Besançon and 14 other locations)
• Trial ID: NCT05529251 on ClinicalTrials.gov

What this trial studies

This phase II, multicenter, prospective, randomized study aims to evaluate de-escalation strategies for patients with stage IIa/IIb seminoma after orchiectomy. Participants will receive one cycle of Etoposide-Cisplatin chemotherapy, and those with a negative PET scan after treatment will be randomized to either receive a radiotherapy boost or an additional cycle of carboplatin chemotherapy. The study seeks to minimize toxicities while maintaining treatment efficacy, addressing the controversial optimal treatment choice for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage IIa/IIb seminoma measuring less than 3 cm after orchiectomy.

Not a fit: Patients with prior treatment for seminoma or those with poor prognostic indicators according to IGCCCG may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to reduced treatment-related toxicities for patients with early-stage seminoma while maintaining effective cancer control.

How similar studies have performed: Previous studies have indicated that de-escalation strategies in seminoma treatment can be feasible and safe, suggesting potential for success in this approach.

Eligibility criteria

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),
   * Direct and total 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.

Where this trial is running

Besançon and 14 other locations

• CHU Besançon — Besançon, France (NOT_YET_RECRUITING)
• CHU Bordeaux — Bordeaux, France (RECRUITING)
• Centre François Baclesse — Caen, France (RECRUITING)
• Centre Jean Perrin — Clermont-Ferrand, France (RECRUITING)
• Centre Oscar Lambret — Lille, France (RECRUITING)
• CHU de Limoges — Limoges, France (RECRUITING)
• Centre Leon Bérard — Lyon, France (RECRUITING)
• Institut Paoli Calmettes — Marseille, France (RECRUITING)
• Centre Antoine Lacassagne — Nice, France (RECRUITING)
• Hôpital Saint Louis — Paris, France (NOT_YET_RECRUITING)
• ICO René Gauducheau — Saint-Herblain, France (RECRUITING)
• Hôpital Foch — Suresnes, France (NOT_YET_RECRUITING)
• Institut Universitaire de Cancer de Toulouse (IUCT-O) — Toulouse, France (RECRUITING)
• Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (NOT_YET_RECRUITING)
• Institut Gustave Roussy — Villejuif, France (RECRUITING)

Study contacts

• Principal investigator: Aude FLECHON, Dr — Centre Leon Berard (Lyon, France)
• Study coordinator: Ellen BLANC

Conditions: Seminoma, Stage II, De-escalation, Chemotherapy, Radiotherapy, Carboplatin, Etoposide, Cisplatine