A MULTICENTER RANDOMIZED PHASE III STUDY COMPARING FIXED DOSES WITH TOXICITY-ADJUSTED DOSES OF STANDARD CHEMOTHERAPY WITH CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY ADVANCED SMALL CELL LUNG CANCER - STAD-1
- Conditions
- Small cell lung cancerMedDRA version: 9.1Level: LLTClassification code 10059514Term: Small cell lung cancer metastatic
- Registration Number
- EUCTR2006-003995-36-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Cytologic or hystologic diagnosis of SCLC; Extended stage of disease; at least one target lesion; Performance status (ECOG) 0 - 1; age < 70 years; written informed consent
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Previuos chemotherapy; previous or concomitant malignancy; Neutrophils < 1.5 x 109/L, platelets < 100 x 109/L, and hemoglobin < 10 g/dL; Bilirubin level either normal or > 1.5 x ULN; AST (SGOT) and ALT (SGPT)> 2.5 x ULN; Serum creatinine > 1.5 x ULN; hypersensitivity to darbepoetin alfa, r-HuEPO or any inactive ingredients; uncontrolled hypertension.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the activity (in terms of objective responses)of a chemotherapy regimen (cisplatin in combination with etoposide) based on ?toxicity ? adjusted dosing?, with a chemotherapy regimen containing the same drugs at standard doses, as first-line therapy of patients affected by advanced SCLC.;Secondary Objective: To describe the feasibility of ?toxicity ? adjusted dosing? regimen, in terms of dose levels and toxicity; to compare the two regimens in terms of progression-free survival and overall survival; to describe the treatment of anemia with darbepoetin alfa, in terms of patients who need the treatment, levels of haemoglobin during the study, number of required blood cell transfusions, compliance to chemotherapy.;Primary end point(s): na
- Secondary Outcome Measures
Name Time Method