PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC)

NCT00173524 | Unknown

• 1 other identifier: 9461700718
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

EGFR Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2-3 years

Interventions

PharmacoEconomic Assessment BEHAVIORAL

Collecting PE data.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients accrued to a gefitinib first line prospective study.

You may qualify if:

• 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

You may not qualify if:

• 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;
• nd 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lin Zone-Zhe, M.D.

  Department of Oncology , National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Cheng Ann-Lii, M.D.,Ph.D.

  Department of Oncology , National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: May 19, 2009

Record last verified: 2009-04

Locations

TW (1)