Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)
Inclusion Criteria
Main inclusion Criteria:
- Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA.
- ECOG Performance Status of 0 - 1
- Bidimensionally measurable disease or evaluable disease
- Adequate organ function
Main exclusion Criteria:
- Have greater than Grade 1 neuropathy - motor/sensory
- Significant history of cardiac disease
- Pleural effusion
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
baseline to measure progressive disease
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Chair
Investigator Affiliation:
Eli Lilly and Company
Authority:
Italy: Ministry of Health
Study ID:
3532
NCT ID:
NCT00191126
Start Date:
September 2000
Completion Date:
September 2007
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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