CTRI/2014/09/005041
Recruiting
Phase 4
Comparative study evaluating Quality Of Life of chemotherapy versus Oral TKI in third line and beyond Setting for advanced non-small cell lung cancer
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients of Advanced Lung cancer
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria :
- •TKI\-naive patients with documented stage IIIB ( treated with palliative intent) or stage IV NSCLC who have progressed on first and second line chemotherapy regimens
- •.2\. ECOG Performance status (PS) from 0 to 2
- •3\. Age \>\= 18yrs
- •4\. Adequate bone marrow tests (absolute neutrophil count \>1500/lL, hemoglobin \> 8 g/dL, and platelet count \>100,000/lL), renal function tests (creatinine \<2 mg/dL), and liver function tests (total bilirubin \<1\.5 times the institutional upper limit of normal \[ULN], aspartate aminotransferase and alanine aminotransferase levels \<2 times the institutional ULN);
- •5\. Life expectancy \>\= 3 months
- •6\. Clinically stable brain metastases if any
Exclusion Criteria
- •1\.Prior therapy with TKI
- •2\.Patients with EGFR mutation
- •3\. A second primary tumor
- •4\. Uncontrolled infection
- •5\.Uncontrolled co\-morbidities
Outcomes
Primary Outcomes
Not specified
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