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Sponsors and Collaborators: |
University Health Network, Toronto AstraZeneca |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00188617 |
ELIGIBILITY
PRE-TREATMENT INVESTIGATIONS
TREATMENT
EVALUATIONS ON TREATMENT
DURATION OF TREATMENT
Condition | Intervention | Phase |
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Lung Cancer |
Drug: GEFITINIB |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study Of Single Agent Gefitinib (Iressa) In Patients With Clinical Stage I Non-Small Cell Lung Cancer (NSCLC) Proceeding To Mediastinoscopy And Surgery |
Estimated Enrollment: | 42 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | November 2009 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
or 1B (T2N0M0 a tumor with any of the following features of size or extent: More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to the carina. Invades the visceral pleura. Associated with atelectasis or obstructive pneumonitis that extends to the hilar region but does not involve the entire lung).
Exclusion Criteria:
Canada, Ontario | |
Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Thomas Waddell, MD FRCSC | University Health Network, Toronto |
Responsible Party: | University Health Network ( Natasha Leighl & Thomas Waddell ) |
Study ID Numbers: | UHN REB04-0420-C, ASTRA ZENECA study D7913L00038 |
Study First Received: | September 12, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00188617 History of Changes |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
LUNG CANCER IRESSA GEFITINIB |
STAGE 1A & 1B NEOADJUVANT PHASE 2 |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Protein Kinase Inhibitors Gefitinib Carcinoma, Non-Small-Cell Lung |
Thoracic Neoplasms Respiratory Tract Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Therapeutic Uses Gefitinib |