Standard treatment compared to intensified treatment with pegfilgrastim support in patients with small-cell lung cancer, limited disease. A phase III study. - The STING 2 study
- Conditions
- Small Cell Lung Cancer (limited disease)
- Registration Number
- EUCTR2006-005754-80-SE
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 128
Histologically verified diagnosis of small cell lung cancer
Limited disease as stage I,II or III
Performance status <= 2
Leukocyte count (LPC) > 3 * 10(9)/L
Thrombocyte count (TPC) > 100*10(9)/L
ASAT/ALAT < 3 * normal value
Crreatinine < 1.5 * normal value
Age 18-75 years
Formerly untreated patients
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) yes
F.1.3.1 Number of subjects for this age range
Serious heart disease, kidney disease, impaired lung function or other disease which may pose risk to standard treatment
Reduced ability to cooperate
Performance status 3 and 4
History of malignant disease other than basal cell carcinoma or stage I cancer of the cervix
Pregnant or breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 2 year survival;Secondary Objective: 5 year survival and overall survival as well as toxicity, frequency of CR and good PR;Primary end point(s): 2 year survival
- Secondary Outcome Measures
Name Time Method