Testicular Cancer Clinical Trial
Official title:
Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
Germ cell tumors, a relatively rare disease, but most common malignancy in young males,
occur most frequently in testis. The incidence is about 1%, but is increasing in the
majority of developed countries. The testicular cancer is an extremely important oncological
condition due to his high rate of 80-90% of curability, which can be achieved by combination
of chemotherapy and surgery.
Some of 20-30% of patients will experience disease progression after first line
cisplatin-based chemotherapy and salvage 2nd line conventional-dose cisplatin-based salvage
chemotherapy will result in long term remissions in < 50% of patients (VeIP - vinblastine,
ifosfamide, cisplatin, VIP/PEI - ifosfamide, etoposide, cisplatin, TIP - paclitaxel,
ifosfamide, cisplatin). In multiple relapsed patients the 3rd line chemotherapy can induce
remission in up to 40% (gemcitabine, oxaliplatin), 23% RR (TG - paclitaxel, gemcitabine),
20% CR (IPO - irinotecan, paclitaxel, oxaliplatin), but only small proportion of them can be
cured, usually with subsequent consolidation surgery. At that stage the disease is usually
chemorefractory and there are no other chemotherapy regimens of proven benefit (7).
The purpose of this study is to determine if multiple-relapsed chemorefractory pts may
benefit from sorafenib monotherapy.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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