TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
Cycle 1: BEP regimen Serum tumor markers at day 18-21: •Patients with an unfavorable pattern of tumor marker decrease after 1 cycle of BEP will receive 4 more cycles of TIP. TIP regimen: * Taxol 250 mg/ m2 iv on day 1 * Ifosfamid 1,2 g/ m2/ day iv x 5 days * Cisplatin 20 mg/ m2/ day iv x 5 days One cycle of therapy consists of 22 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
National Cancer Institute
Bratislava, Slovakia
Complete response rate
according RECIST criteria version 1.1
Time frame: 36 month
Response rate
response rate after chemotherapy
Time frame: 36 month
Progression-free survival
expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate
Time frame: 36 month
Number of adverse events grade III and IV
Time frame: 36 month
overall survival
Survival will be estimated from the registration date to the date of last follow-up or death. Patients will be followed at least 3 years.
Time frame: 36 months
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