Carboplatin for Stage II seminoma

Inclusion criteria

• {"criterion_text":"- I1. Age ≥ 18 years on the day of signing informed consent.\n- I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n- 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.\n- I12. Affiliation to a health insurance\n- I13. Signed and dated informed consent.\n- I2. Primary testicular seminomatous germ cell tumor.\n- I3. Stage IIa/IIb N < 3 cm in largest diameter seminoma, histologically proved after orchiectomy.\n- I4. Confirmation of a progressive disease (positive FDG-PET or increase of lymph nodes size by two successive CT scan).\n- I5. Good prognosis according to IGCCCG and LDH < 2.5 x ULN\n- I6. Normal AFP before and after orchiectomy\n- I7. No prior treatment with radiotherapy or chemotherapy\n- I8. ECOG PS ≤ 2\n- 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)."}

Exclusion criteria

• {"criterion_text":"- NI1. Extra-retroperitoneal metastasis on CT-scan.\n- NI2. Infection by HIV, or active infection with the Hepatitis B or C virus\n- NI3. History, within 2 years, of cancer other than seminoma, except for treated skin cancer (basal cell).\n- NI4. Uncontrolled or severe cardiovascular pathology.\n- NI5. Uncontrolled or severe hepatic pathology.\n- NI6. Patient deprived of liberty or requiring tutorship or curatorship\n- NI7. Psychological, physical, sociological, or geographical conditions that would limit compliance with study protocol requirements (at the investigator’s discretion).\n- NI8. Participation to another clinical trial, except for supportive care trials."}

Primary endpoints

• {"endpoint_text":"- the progression-free rate at 36 months (PFR-36m) defined as the proportion of patients with a complete response (CR), a partial response (PR) or a stable disease (SD) at 36 months according to RECIST v1.1. Prevalence of events (relapse or death) is expected to be low","definition_or_measurement_approach":"Defined as the proportion of patients with CR, PR or SD at 36 months assessed according to RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- Association between serum level of miRNA-M371 (MiRNA-M371 expression rate measured before the introduction of chemotherapy, before the second cycle of chemotherapy (EP or carboplatin) or before the beginning of radiotherapy and at the end of treatment) and response to treatment (according to RECIST v1.1)","definition_or_measurement_approach":"MiRNA-M371 expression measured at specified timepoints (before chemotherapy, before cycle 2, before RT if applicable, and at end of treatment) correlated with response per RECIST v1.1."}
• {"endpoint_text":"- Correlation between serum level of miRNA-M371 and FDG-PET results (complete metabolic response),","definition_or_measurement_approach":"Correlation analysis between miRNA-M371 serum levels and FDG-PET metabolic response (complete metabolic response)."}
• {"endpoint_text":"- OS, defined as the time from the date of inclusion to the date of death from any cause. Any 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","definition_or_measurement_approach":"Overall survival measured from inclusion date to date of death from any cause; censoring at last known alive date."}
• {"endpoint_text":"- QoL, assessed using the EORTC QLQ-C30 (baseline, at the end of treatment visit).","definition_or_measurement_approach":"Quality of life measured with EORTC QLQ-C30 at baseline and end of treatment."}
• {"endpoint_text":"- Safety profile, determined using the NCI-CTC AE grading scale version 5. Adverse events will be described by their intensity and severity.","definition_or_measurement_approach":"Safety assessed using NCI-CTCAE v5.0; AEs described by intensity and severity per grading scale."}

France

Earliest CTIS Part Ii Submission Date

17-05-2024

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

675

Number Of Sites

18

Number Of Participants

90

Primary sponsor

Full Name

Centre Leon Berard

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France