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NCT00373425
RADIANT: A Study of Tarceva After Surgery With or Without Adjuvant Chemotherapy in Non-small Cell Lung Carcinoma (NSCLC) Patients Who Have EGFR-positive Tumors (Adjuvent)
Tracking Information
Start Date ICMJE | September 2006 |
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Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: October 5, 2009) | Disease Free Survival [ Time Frame: 3 Months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: January 16, 2008) | Disease Free Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ] |
Change History | Complete list of historical versions of study NCT00373425 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: October 5, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: January 16, 2008) | Safety, Overall Survival [ Time Frame: 7 years ] [ Designated as safety issue: Yes ] |
Descriptive Information
Brief Title ICMJE | RADIANT: A Study of Tarceva After Surgery With or Without Adjuvant Chemotherapy in Non-small Cell Lung Carcinoma (NSCLC) Patients Who Have EGFR-positive Tumors |
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Official Title ICMJE | RADIANT: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors |
Brief Summary | This is a study to evaluate the effectiveness of Tarceva erlotinib vs. placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Non-small Cell Lung Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 945 | ||||||||
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Estimated Completion Date | September 2013 | ||||||||
Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00373425 | ||||
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Responsible Party | Angela Davies, OSI Pharmaceuticals | ||||
Study ID Numbers ICMJE | OSI-774-302 | ||||
Study Sponsor ICMJE | OSI Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | OSI Pharmaceuticals |
Source: http://clinicaltrials.gov/