Status:
UNKNOWN
PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC)
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
20+ years
Brief Summary
The objective of this pharmacoeconomics (PE) study is to evaluate the cost- effectiveness analysis and cost-utility analysis of IRESSA® as first line treatment of NSCLC from the society perspective, b...
Detailed Description
Patients with late-stage NSCLC are often symptomatic, with specific pulmonary problems (eg, cough, breathlessness, hemoptysis) and general symptoms (eg. fatigue, weight loss) that can cause extreme di...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed stage IIIB/IV NSCLC No immediate need for palliative radiotherapy and No prior chemotherapy ; age \> 20 Y/O; ECOG PS: 0 - 2; ANC \>2000 ; PLT \>100k ; Hb \> 10; total bilirubin \< 2.0 mg/dL; serum creatinine \< 2 mg/dl; SGPT and SGOT \< 2.5 ×ULN, alkaline phosphatase \< 5 ×ULN ; life expectancy \>6mos
Exclusion
- If the patients have brain metastases or receive radiotherapy, the disease must be stable for more than 6 weeks after the last dose of radiotherapy;
- 2nd malignancies;
- Unable to swallow tablets;
- Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements;
- Pregnant or lactating patients;
- Participation in other clinical trials within 30 days of study entry;
- Major systemic disease which in the investigator's opinion might confound the clinical trial.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00173524
Start Date
September 1 2005
End Date
September 1 2005
Last Update
May 19 2009
Active Locations (1)
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1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan