Accelerated v’s Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (P3BEP)

NCT 02582697

Brief Summary

Inclusion Criteria:

1. Age ≥ 11 years and ≤ 50 years on the date of randomisation
2. Histologically or cytologically confirmed germ cell tumoura tissue mass that forms from groups of unhealthy cells (non-seminoma or seminoma); or Exceptionally raised tumour markersa substance in the body that can be used to indicate cancer, these substances are often made by cancer cells (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 mediastinumthe space between the lungs that holds many important structures, including the heart, trachea and oesophagus
4. Metastatic disease or non-testicular primary
5. Intermediate or poor prognosisto predict how a disease/condition may progress and what the outcome might be as defined by IGCCC classification3 (modified with different LDH criteria for intermediate riskthe possibility that something bad will happen non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).
6. Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells 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 or borderline in which case GFR should be formally measured, eg. with EDTA scan
9. ECOG Performance Status of 0, 1, 2, or 3
10. Study treatment both planned and able to start within 14 days of randomisation.
11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
12. Able to provide signed, written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.