NON SMALL CELL LUNG CANCER (NSCLC) MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Interventions
Trade Name: ELOXATIN
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Oxaliplatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: TAX
Sponsors
ISTITUTO DERMOPATICO IMMACOLATA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age  18 years; both M/F; histological diagnosis of Stage IIIB (not susceptible of CH and/or RT, meaning supraclavear and/or laterocervical node involvement, pleural effusion), Stage IV NSCLC; not previuosly treated with chemotherapy for advanced disease. no second malignancy, except adequately treated in situ carcinoma of the cervix or non melanomic skin cancer; ECOG performance status 0-2; life expectancy of at least 3 months; no previous thoracic radiotherapy; complete work-up at least 3 weeks or less before inclusion; WBC, Neutrophils, RBC, Hgb, Platelets within normal ranges ( WBC > 3000; Neut.> 2000; Hgb > 9 g/dl; PLT >100.000 ); liver and renal function assessed as normal ( AST=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: previous chemotherapy; symptomatic or not irradiated brain metastases; bone metastases as only disease evidence; pregnancy or breastfeeding status. Pre-menopausal patients must undergo contrapcetive therapies; serious and/or life-threatning co-morbidities: severe cardiac impairment, unstable angina, recent myocardial infarction, arrythmia, epilepsy, dementia, severe neurologic and/or psychiatric syndromes, ongoing infections, hypercalcemia, uncontrolled diabetes, severe pulmonary disease. second malignancy, except adequately treated in situ carcinoma of the cervix or non melanomic skin cancer; WBC, Neutrophils, RBC, Hgb, Platelets within no normal ranges (see above); liver and renal function assessed abnormal (see above);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: response rate toxicity evaluation;Secondary Objective: progression free survival (TTP); overall survival; identification of factors conditioning response to treatment; response duration;Primary end point(s): response rate toxicity evaluation | — |
Countries
Italy
Outcome results
None listed