Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00049543|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Squamous Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer||Drug: gefitinib Other: placebo Other: laboratory biomarker analysis||Phase 3|
I. To assess, in comparison with placebo, the impact of adjuvant therapy with two years of daily oral ZD1839 (IRESSA) (gefitinib) on the overall survival of patients with completely resected (T1N1-2, T2N0-2, T3N0-2) non-small cell lung cancer (NSCLC).
I. To compare the disease-free survival in the placebo arm to the ZD1839 (IRESSA) arm.
II. To confirm the prognostic significance of epidermal growth factor receptor (EGFR) expression, phosphorylation and mutations when present in the primary tumor.
III. To assess the ability of EGFR expression, phosphorylation and mutations in the primary tumor to predict the relative impact of ZD1839 (IRESSA) on survival.
IV. To establish a comprehensive tumour bank linked to a clinical database for the further study of molecular markers in resected NSCLC.
V. To further evaluate toxicity related to ZD1839 (IRESSA).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive gefitinib orally (PO) once daily (QD) for 2 years in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 6 months, every 6 months for 3 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||503 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (IRESSA) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer|
|Study Start Date :||September 2002|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Experimental: Arm I (gefitinib)
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
Other Name: PLCBOther: laboratory biomarker analysis
- Overall Survival [ Time Frame: From randomization to the time of death from any cause, assessed up to 5 years ]The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported.
- Disease Free Survival [ Time Frame: From randomization to the time of documented recurrence of the primary cancer, assessed up to 5 years ]The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the disease free survival between two arms adjusting for the stratification factors. Five years disease free survival rate will be reported.
- Incidence of Toxicities Graded Using the NCI Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ]The incidence of toxicities will be summarized by type of adverse event and severity. A Fisher's exact test will be used to compare toxicities between the two arms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049543
|National Cancer Institute of Canada Clinical Trials Group|
|Kingston, Ontario, Canada, K7L 3N6|
|Principal Investigator:||Glennwood Goss||Canadian Cancer Trials Group|