Germ Cell Tumor
Conditions
Keywords
poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline
Brief summary
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.
Detailed description
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.
Interventions
DRUGPaclitaxel
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
DRUGIfosfamide
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
DRUGCisplatin
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
Sponsors
National Cancer Institute, Slovakia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 16 years. * Evidence of NSGCT based on histologic examination or based on clinical evidence and high serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are very elevated) * Testicular, retroperitoneal, or mediastinal primary site. * Evidence of disseminated disease (clinical stages II or III). * 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 previous carcinoma, except basal-cell carcinoma of the skin. * Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min. * Absolute granulocyte count \>= 1,500/mm3, platelets \>= 100,000 mm3, bilirubine \<= 1.5 fold the upper normal value. * Unfavorable tumor marker decline after 1.cycle of BEP * Signed informed consent.
Exclusion criteria
* Patients infected by the Human Immunodeficiency Virus (HIV). * Patients who do not fit inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | 36 month | according RECIST criteria version 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 36 month | response rate after chemotherapy |
| Progression-free survival | 36 month | expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate |
| Number of adverse events grade III and IV | 36 month | — |
| overall survival | 36 months | 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. |
Countries
Slovakia
Outcome results
None listed