SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients (SELINE)
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|ClinicalTrials.gov Identifier: NCT00608868|
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Carcinoma||Drug: Gefitinib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
- Drug: Gefitinib
Gefitinib tablet 250mg once daily orally
- Objective Response Rate(ORR) [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]
Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated.
According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
- Period of Progression-Free Survival [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]The median months without event of progression disease according to RECIST criteria is analysed.
- Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]
Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0~4 scale (0=not at all to 4=very much). A possible score was 0~28.
The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L.
The percentage of patients who showed improvement is reported.
- Overall Survival [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death. ]
- Adverse Event [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608868
|Korea, Republic of|
|Daegu, Korea, Republic of|