OncoMatch/Clinical Trials/NCT02582697
Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
Is NCT02582697 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for germ cell tumor.
Treatment: Bleomycin (active name: Bleomycin Sulfate) · Etoposide · Cisplatin · Pegylated G-CSF (Pegfilgrastim) · Filgrastim — The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
Check if I qualifyExtracted eligibility criteria
Cancer type
Testicular Germ Cell Tumor
Biomarker criteria
Required: AFP overexpression (AFP ≥ 1000ng/mL)
Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently
Required: CGB overexpression (HCG ≥ 5000 IU/L)
Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently
Disease stage
Metastatic disease required
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin; non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour with low-dose induction chemotherapy prior to registration due to poor fitness (acceptable regimens: cisplatin 20 mg/m2 days 1-2 and etoposide 100 mg/m2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m2 days 1-2; or baby-BOP)
Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). Acceptable regimens include cisplatin 20 mg/m2 days 1-2 and etoposide 100 mg/m2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m2 days 1-2; or baby-BOP.
Cannot have received: radiotherapy
Exception: pure seminoma relapsing after adjuvant radiotherapy
Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy
Lab requirements
Blood counts
ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L
Kidney function
estimated creatinine clearance of ≥60 ml/min according to Cockcroft-Gault formula, or GFR formally measured if <60 ml/min or borderline
Liver function
bilirubin ≤1.5 x ULN (≤2.0 x ULN if Gilbert's Syndrome); ALT and AST ≤2.5 x ULN (≤5 x ULN if due to hepatic metastases)
Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L; Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN; Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Centre · New York, New York
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