Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC
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ClinicalTrials.gov Identifier: NCT00191126 |
Recruitment Status
:
Completed
First Posted
: September 19, 2005
Last Update Posted
: November 22, 2016
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
Tracking Information | |||||
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First Submitted Date ICMJE | September 12, 2005 | ||||
First Posted Date ICMJE | September 19, 2005 | ||||
Last Update Posted Date | November 22, 2016 | ||||
Study Start Date ICMJE | September 2000 | ||||
Actual Primary Completion Date | September 2007 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression free survival [ Time Frame: baseline to measure progressive disease ] | ||||
Original Primary Outcome Measures ICMJE |
To assess whether preoperative chemotherapy with gemcitabine and cisplatin for 3 cycles improves progression-free survival compared to surgery alone in previously untreated patients with clinical Stage IB, II and Selected III A non-small cell lung cancer | ||||
Change History | Complete list of historical versions of study NCT00191126 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC | ||||
Official Title ICMJE | 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) | ||||
Brief Summary | Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | Scagliotti GV, Pastorino U, Vansteenkiste JF, Spaggiari L, Facciolo F, Orlowski TM, Maiorino L, Hetzel M, Leschinger M, Visseren-Grul C, Torri V. Randomized phase III study of surgery alone or surgery plus preoperative cisplatin and gemcitabine in stages IB to IIIA non-small-cell lung cancer. J Clin Oncol. 2012 Jan 10;30(2):172-8. doi: 10.1200/JCO.2010.33.7089. Epub 2011 Nov 28. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
263 | ||||
Original Enrollment ICMJE |
700 | ||||
Actual Study Completion Date | September 2007 | ||||
Actual Primary Completion Date | September 2007 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Main inclusion Criteria:
Main exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium, Bosnia and Herzegovina, Bulgaria, Egypt, Estonia, Germany, Hungary, Italy, Lithuania, Poland, Romania, Saudi Arabia, Slovakia, Sweden, Taiwan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00191126 | ||||
Other Study ID Numbers ICMJE | 3532 B9E-MC-S132 ( Other Identifier: Eli Lilly and Company ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Eli Lilly and Company | ||||
Study Sponsor ICMJE | Eli Lilly and Company | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Eli Lilly and Company | ||||
Verification Date | November 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |