Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

Tracking Information
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; (submitted: December 20, 2007)	Progression free survival [ Time Frame: baseline to measure progressive disease ]
Original Primary Outcome Measures ICMJE; (submitted: September 12, 2005)	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; (submitted: December 20, 2007)	To compare the survival and sites of relapse in the two study arms. [ Time Frame: baseline to progressive disease ]; Pharmacology toxicity [ Time Frame: every cycle ]; Response rate [ Time Frame: baseline to measured progressive disease ]; Pathologic response rate of tissue samples [ Time Frame: baseline, post chemotherapy, post surgery ]
Original Secondary Outcome Measures ICMJE; (submitted: September 12, 2005)	To compare the survival and sites of relapse in the two study arms.; To compare operative mortality and other toxicities in the two study arms.; To evaluate the response rates (confirmed and unconfirmed) and the toxicities associated with the combination of; gemcitabine and cisplatin.; To obtain samples for correlation of radiologic, pathologic, molecular and biologic factors with outcome.
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
Condition ICMJE	Non-Small Cell Lung Cancer
Intervention ICMJE	Drug: gemcitabine 1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles Other Names: LY188011 Gemzar; Drug: Cisplatin 75 mg/m2, IV, q 21 days x 3 cycles; Procedure: surgery surgery
Study Arms	A Intervention: Procedure: surgery; Experimental: B Interventions: Drug: gemcitabine Drug: Cisplatin Procedure: surgery
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 20, 2008)	263
Original Enrollment ICMJE; (submitted: September 12, 2005)	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: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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 )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Responsible Party	Eli Lilly and Company
Study Sponsor ICMJE	Eli Lilly and Company
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: 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) Eli Lilly and Company
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