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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191126
First received: September 12, 2005
Last updated: November 21, 2016
Last verified: November 2016

September 12, 2005
November 21, 2016
September 2000
September 2007   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: baseline to measure progressive disease ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00191126 on ClinicalTrials.gov Archive Site
  • To compare the survival and sites of relapse in the two study arms. [ Time Frame: baseline to progressive disease ] [ Designated as safety issue: No ]
  • Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Pathologic response rate of tissue samples [ Time Frame: baseline, post chemotherapy, post surgery ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • 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
  • A
    Intervention: Procedure: surgery
  • Experimental: B
    Interventions:
    • Drug: gemcitabine
    • Drug: Cisplatin
    • Procedure: surgery
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
263
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bosnia and Herzegovina,   Bulgaria,   Egypt,   Estonia,   Germany,   Hungary,   Italy,   Lithuania,   Poland,   Romania,   Saudi Arabia,   Slovakia,   Sweden,   Taiwan
 
NCT00191126
3532, B9E-MC-S132
Yes
Yes

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.

Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP