OncoMatch/Clinical Trials/NCT05529251
De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
Official title: Prospective Therapeutic De-escalation and miRNA-M371 Biomarker Evaluation Phase II Study for Stage IIa/IIb < 3 cm Seminomas
Is NCT05529251 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Carboplatin AUC7 and 3 cycles of EP for seminoma.
Treatment: Carboplatin AUC7 · 3 cycles of EP — 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. 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Testicular Germ Cell Tumor
Biomarker criteria
Required: AFP wild-type (normal)
Disease stage
Required: Stage IIA, IIB
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: radiation therapy
No prior treatment with radiotherapy
Cannot have received: cytotoxic chemotherapy
No prior treatment with chemotherapy
Lab requirements
Blood counts
Neutrophils ≥ 1.5 x Giga/l, platelets ≥ 100 x Giga/l
Kidney function
Serum creatinine < 140 µmol/l OR calculated clearance > 60 ml/min (Cockcroft-Gault or MDRD for > 65 years old)
Liver function
AST and ALT ≤ 1.5 x ULN; total bilirubin ≤ ULN (if > ULN, direct bilirubin ≤ ULN)
Adequate bone-marrow, hepatic, and renal functions with: Neutrophils ≥ 1.5 x Giga/l, platelets ≥ 100 x Giga/l, AST and ALT ≤ 1.5 x ULN, Serum creatinine < 140 µmol/l OR calculated clearance > 60 ml/min, Total bilirubin ≤ ULN (if > ULN, direct bilirubin ≤ ULN)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05529251 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require AFP?
Yes, AFP wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIA or IIB is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages