Paclitaxel-Bleomycin/Etoposide/Cisplatin vs Bleomycin/Etoposide/Cisplatin in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial

Inclusion Criteria:

* Age ≥16 years;
* Evidence of NSGCT based on histologic examination or clinical evidence (high serum HCG or AFP levels - in case of clinical emergency due to bulky disease, therapy can be started without pathological confirmation of the disease);
* Testicular, retroperitoneal, or mediastinal primary site;
* Disease classified as poor prognosis according to IGCCCG criteria:

  * Primary mediastinal NSGCT or
  * Non-pulmonary visceral metastases or
  * HCG \> 50,000 UI/l, or AFP \> 10,000 ng/ml, or LDH \> 10 times the upper normal value.
* No prior chemotherapy;
* No concurrent malignancies which may have an impact of anticipated lifespan (ie, malignancies other than basal-cell skin carcinoma, in situ carcinomas, borderline ovarian tumors etc);
* Adequate renal function: measured or calculated glomerular filtration rate \> 60 ml/min.
* Absolute baseline granulocyte count ≥0.5\*10\^9, platelets ≥100\*10\^9, bilirubin ≤1.5 ULN.
* Unfavorable tumor marker decline after 1st cycle of standard BEP chemotherapy calculated according to time to normalization from the K. Fizazi study in JCO 2004.
* Signed informed consent before protocol-specific procedures.

Exclusion Criteria:

* Primary intracranial germ-cell tumors;
* Patients with seminomas or dysgerminomas;
* Patients with normal range of serum tumor markers before starting treatment;
* Patients with favorable tumor markers decline;
* Patients infected by the Human Immunodeficiency Virus (HIV);
* Patients with contraindications to taxane agents (hypersensitivity to paclitaxel);
* Patients who do not fit inclusion criteria.