Non-Seminoma Germ Cell Tumor MedDRA version: 14.0 Level: LLT Classification code 10018207 Term: Germinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ELOXATINE
Product Name: OXALIPLATIN
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825943
Concentration unit: mg milligram(s)
Concentr
Sponsors
FNCLCC
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1-Patients older than 16 years. 2-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 elevated) 3-Testicular, retroperitoneal, or mediastinal primary site. 4-Evidence of disseminated disease (clinical stages II or III). 5-Disease classified as poor prognosis according to IGCCCG criteria: - Primary mediastinal NSGCT (any stage) 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. 6-No prior chemotherapy. 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. Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)] (for females, multiply by 0.85) 9-Absolute granulocyte count >or= 1,500/mm3, platelets > or = 100,000 mm3, bilirubine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1-Patients infected by the Human Immunodeficiency Virus (HIV). 2-Patients who do not fit inclusion 3-Female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the progression-free survival rates of patients with poor prognosis NSGCT and an unfavorable decrease of tumor markers after 1cycle of the BEP regimen, randomly treated either by 3 subsequent cycles of BEP or by a dose-dense regimen called T-BEP-Oxali/Plat-Ifo-Bleo;Secondary Objective: 1.To evaluate the response rate, overall survival rate and toxicity in both treatment groups (control and study group) with unfavorable decrease in the serum tumor markers. 2.To evaluate the response rate, progression-free survival, overall survival and toxicity in patients with a favorable decrease in the serum levels of tumor markers. ;Primary end point(s): Primary: Progression-free survival | — |
Countries
Denmark
Contacts
Public ContactGedske DAUGAARD
Rigshospitalet, Department of Oncology
Outcome results
None listed