Disseminated Non-Seminomatous Germ Cell Tumors. MedDRA version: 21.1 Level: PT Classification code 10061184 Term: Germ cell cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Holoxan
Product Name: ifosfamide
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: IFOSFAMIDE
CAS Number: 3778-73-2
Trade Name: Paclitaxel Kabi
Product Name: pacl
Sponsors
Národný onkologický ústav
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. 2. Patients older than 18 years. 3. Evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are highly elevated) 4. Testicular, retroperitoneal, or mediastinal primary site. 5. Evidence of disseminated disease (clinical stages II or III). 6. 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. 7. No previous malignancy, except for basal-cell carcinoma of the skin. 8. Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance> 60 ml/min. 9. Cockcroft formula: CrCl = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)] 10. Absolute neutrophil count ? 1,500/mm3, platelets ? 100,000 mm3, bilirubin ? 1.5x the upper limit of normal value. 11. Unfavorable tumor marker decline after 1.cycle of BEP in first line setting. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: 1. Patients with known Human Immunodeficiency Virus (HIV) infection. 2. Patients who do not fit inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy (defined as complete response rate) of TIP in the 1st line treatment of patients with poor prognosis NSGCT and an unfavorable decrease in the serum level of tumor markers after 1 cycle of the BEP regimen. ;Secondary Objective: To evaluate the progression-free and overall survival rate and toxicity of TIP regimen in patients with poor prognosis NSGCT and an unfavorable decrease in the serum tumor markers after 1 cycle of BEP.;Primary end point(s): Complete Response rate;Timepoint(s) of evaluation of this end point: 7 years and follow up until end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate, overall survival and toxicity, progression-free survival, overall survival and toxicity in patients with a unfavorable decrease of tumor markers;Timepoint(s) of evaluation of this end point: 7 years and follow up until end of study for efficacy, for toxicity from day 1 cycle 1 to safety follow up | — |
Countries
Slovakia
Contacts
Public ContactProf Michal Mego MD, DSc
Národný onkologický ústav
Outcome results
None listed