Docetaxel and Carboplatin once every 3 weeks versus weekly Docetaxel in advanced non-small cell lung cancer: a Multicenter phase III study from the Dutch Chest Physician Association.
Completed
- Conditions
- on small cell lung cancer (NSCLC)
- Registration Number
- NL-OMON28184
- Lead Sponsor
- MCGDepartment Pulmonary Diseases
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 440
Inclusion Criteria
1. Histological or cytological diagnosis of unresectable (stage III-b, pleuritis carcinomatosa) or disseminated (stage IV) NSCLS;
2. Age ≥ 18 years;
Exclusion Criteria
1. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension, active infection or significant psychiatric illness;
2. Symptomatic brain metastases;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is the overall survival.
- Secondary Outcome Measures
Name Time Method Secondary endpoints are:<br /><br>1. To assess efficary in terms of response rates, time to progression, duration of response and duration of palliation (appendix 5);<br /><br>2. To evaluate toxic effects of treatment (CTC criteria, appendix 2);<br /><br>3. To evaluate the effect of therapy on Quality of Life (appendix 5).