Study of Comparison of Quality of life Questionnaire in patients receiving chemotherapy and Oral TKI in Advanced Lung Cancer.
- Conditions
- Health Condition 1: null- Patients of Advanced Lung cancer
- Registration Number
- CTRI/2014/09/005041
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
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
1.Prior therapy with TKI
2.Patients with EGFR mutation
3. A second primary tumor
4. Uncontrolled infection
5.Uncontrolled co-morbidities
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary â?? Study the QOL in these two regimesTimepoint: At 8-10 Weeks at every OPD visits
- Secondary Outcome Measures
Name Time Method 1. Safetyand Toxicity of these two regimens <br/ ><br>2. PFS and OS in these two regimens <br/ ><br>Timepoint: 1. At every follow up visit <br/ ><br>2. At the end of the study