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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous chemotherapy | Experimental | TIP regimen:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | according RECIST criteria version 1.1 | 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | response rate after chemotherapy | 36 month |
| Progression-free survival | expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Mego, Ass.prof | National Cancer Institute, Slovakia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Bratislava | 83310 | Slovakia |
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| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D007069 | Ifosfamide |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Ifosfamide | Drug | paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements |
|
|
| Cisplatin | Drug | paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements |
|
|
| 36 month |
| Number of adverse events grade III and IV | 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. | 36 months |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |