ClinicaliQ Trial Snapshot
- Accelerated v’s Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours — Recruiting • Phase III • Oncology • NCT02582697.
- What is being tested: Accelerated dosing schedule of BEP chemotherapy (bleomycin, etoposide, cisplatin) compared to standard dosing in men with intermediate and poor-risk metastatic germ cell tumours to determine which regimen achieves better efficacy.
- Patient eligibility overview: Male patients diagnosed with metastatic germ cell tumours classified as intermediate or poor-risk disease according to established prognostic criteria are eligible for this comparative trial.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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.
Eligibility Snapshot
- : 1. Age ≥ 11 years and ≤ 50 years on the date of randomisation 2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or 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 3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum 4. Metastatic disease or non-testicular primary 5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information). 6. Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L 7. 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 8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.