PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC)
Recruitment status was Active, not recruiting
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Purpose
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, based on resources and outcomes from patients who met the inclusion criteria for this naturalistic study comparing to existing first line platinum-based regimen chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Behavioral: PharmacoEconomic Assessment |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC) : A Cost-Effectiveness Analysis and Cost-Utility Analysis |
- The objective of this 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, comparing to existing first line platinum-based regimen chemotherapy. [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2005 |
-
Behavioral: PharmacoEconomic Assessment
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 distress to the patient. Therefore, improvements in disease-related symptoms and quality of life (QoL) are the key desired outcomes of medical management.7 Effective, palliative, low-toxicity with reasonable treatment cost for patients with advanced NSCLC are needed. Recently, more and more countries consider evidence of economic value along with clinical efficacy.
The epidermal growth factor receptor (EGFR) is a promising target for anticancer therapy because it is expressed or highly expressed in a variety of tumors, including NSCLC. 8,9 Furthermore, high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies. 10-12 EGFR-targeted cancer therapies are currently being developed; strategies include inhibition of the intracellular tyrosine kinase domain of the receptor by small molecules such as gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE).13 Iressa is an orally active, selective EGFR tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients accrued to a gefitinib first line prospective study.
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| Taiwan | |
| Department of Oncology, National Taiwan University Hospital | |
| Taipei, Taiwan | |
| Principal Investigator: | Lin Zone-Zhe, M.D. | Department of Oncology , National Taiwan University Hospital |
| Study Chair: | Cheng Ann-Lii, M.D.,Ph.D. | Department of Oncology , National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | Chih-Hsin Yang, National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00173524 History of Changes |
| Other Study ID Numbers: | 9461700718 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 18, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
EGFR Non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013