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EDEN : Etude de désescalade thérapeutique et d'évaluation du marqueur miRNA M371 pour les séminomes de stade IIa/IIb < 3 cm
EU CTIS ID: 2024-514636-25-00
What this study is testing
To evaluate the efficacy of de-escalated therapy [1 cycle of EP (Etoposide cisPlatine) followed, in case of negative FDG-PET at week 3, by either 1 cycle of carboplatin AUC 7 or a boost of radiotherapy (RT) on lymph nodes] on the time to first relapse in patients with stage IIa/IIb < 3 cm seminoma.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- I1. Age ≥ 18 years on the day of signing informed consent.
- I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- I11. 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. Refer to Appendix 1 for approved methods of contraception.
- I12. Affiliation to a health insurance
- I13. Signed and dated informed consent.
- I2. Primary testicular seminomatous germ cell tumor.
You likely can't join if
- NI1. Extra-retroperitoneal metastasis on CT-scan.
- NI2. Infection by HIV, or active infection with the Hepatitis B or C virus
- NI3. History, within 2 years, of cancer other than seminoma, except for treated skin cancer (basal cell).
- NI4. Uncontrolled or severe cardiovascular pathology.
- NI5. Uncontrolled or severe hepatic pathology.
- NI6. Patient deprived of liberty or requiring tutorship or curatorship
See the full eligibility criteria
- I1. Age ≥ 18 years on the day of signing informed consent.
- I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- I11. 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. Refer to Appendix 1 for approved methods of contraception.
- I12. Affiliation to a health insurance
- I13. Signed and dated informed consent.
- I2. Primary testicular seminomatous germ cell tumor.
- I3. Stage IIa/IIb N < 3 cm in largest diameter seminoma, histologically proved after orchiectomy.
- I4. Confirmation of a progressive disease (positive FDG-PET or increase of lymph nodes size by two successive CT scan).
- I5. Good prognosis according to IGCCCG and LDH < 2.5 x ULN
- I6. Normal AFP before and after orchiectomy
- I7. No prior treatment with radiotherapy or chemotherapy
- I8. ECOG PS ≤ 2
- I9. Adequate bone-marrow, hepatic, and renal functions with: - Neutrophils ≥ 1.5 x 109 /l, platelets ≥ 100 x 109 /l, - AST (SGOT) and ALT (SGPT) ≤ 1,5 x ULN, - Serum creatinine < 140 µmol/l OR calculated clearance > 60 ml/min (using either Cockcroft-Gault formula or MDRD for > 65 years old), - Total bilirubin ≤ ULN (if >ULN, direct bilirubin ≤ ULN).
- NI1. Extra-retroperitoneal metastasis on CT-scan.
- NI2. Infection by HIV, or active infection with the Hepatitis B or C virus
- NI3. History, within 2 years, of cancer other than seminoma, except for treated skin cancer (basal cell).
- NI4. Uncontrolled or severe cardiovascular pathology.
- NI5. Uncontrolled or severe hepatic pathology.
- NI6. Patient deprived of liberty or requiring tutorship or curatorship
- NI7. Psychological, physical, sociological, or geographical conditions that would limit compliance with study protocol requirements (at the investigator’s discretion).
- NI8. Participation to another clinical trial, except for supportive care trials.
The study team makes the final eligibility decision.
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 all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.