Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer
A Phase II Study to Evaluate the Efficacy and Safety of Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
108
1 country
1
Brief Summary
The purpose of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Mar 2005
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJuly 30, 2007
July 1, 2005
September 8, 2005
July 27, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer
2005~2007
Secondary Outcomes (1)
To evaluate 1) Individual response rate 2) Time to progression 3) Overall survival (OS) at year1 4) Progression free survival (PFS) at year1 5) Toxicity
2005~2007
Study Arms (1)
A
EXPERIMENTALIressa
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chin-Hsin Yang, M.D.,Ph.D.
Department of Oncology , National Taiwan University Hospital
- STUDY CHAIR
Ann-Lii Cheng, M.D.,Ph.D.
Department of Oncology , National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 15, 2005
Study Start
March 1, 2005
Study Completion
July 1, 2007
Last Updated
July 30, 2007
Record last verified: 2005-07