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New treatment option for Seminoma
Official title De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
ClinicalTrials.gov ID: NCT05529251
What this study is testing
What is Carboplatin AUC7?
Carboplatin AUC7 is an investigational medicine, being studied as a potential treatment for seminoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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 \ 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.
- 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...
- Affiliation to a health insurance.
- Signed and dated informed consent. Non-
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nice, France
- Paris, France
- Saint-Herblain, France
- Suresnes, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
- Villejuif, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Caen, France; Clermont-Ferrand, France; Lille, France; Limoges, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.