S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00045162
First received: September 6, 2002
Last updated: July 3, 2013
Last verified: July 2013
Results First Received: April 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: cisplatin
Drug: etoposide
Drug: irinotecan hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cisplatin + Irinotecan No text entered.
Cisplatin + Etoposide No text entered.

Participant Flow:   Overall Study
    Cisplatin + Irinotecan     Cisplatin + Etoposide  
STARTED     336     335  
COMPLETED     194     217  
NOT COMPLETED     142     118  
Ineligible                 12                 8  
Not treated                 7                 2  
Adverse Event                 55                 50  
Lack of Efficacy                 32                 29  
Death                 10                 10  
Withdrawal by Subject                 5                 3  
Not specified                 21                 16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eleven ineligible patients on the cisplatin + irinotecan arm, and eight ineligible patients on the cisplatin + etoposide arm were excluded from the analysis.

Reporting Groups
  Description
Cisplatin + Irinotecan No text entered.
Cisplatin + Etoposide No text entered.
Total Total of all reporting groups

Baseline Measures
    Cisplatin + Irinotecan     Cisplatin + Etoposide     Total  
Number of Participants  
[units: participants]
  324     327     651  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 22 to 85 )  
  63  
  ( 35 to 88 )  
  62  
  ( 22 to 88 )  
Gender  
[units: participants]
     
Female     136     145     281  
Male     188     182     370  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     7     7     14  
Not Hispanic or Latino     289     288     577  
Unknown or Not Reported     28     32     60  
Race (NIH/OMB)  
[units: particpants]
     
American Indian or Alaska Native     2     0     2  
Asian     4     1     5  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     14     18     32  
White     300     304     604  
More than one race     2     0     2  
Unknown or Not Reported     2     4     6  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment. ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment. ]

3.  Secondary:   Confirmed and Unconfirmed Complete and Partial Responses.   [ Time Frame: Every 6 weeks while on protocol treatment for a maximum of 12 weeks ]

4.  Secondary:   Number of Patients With a Given Type and Grade of Adverse Event.   [ Time Frame: Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lung Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


Publications of Results:
Other Publications:
Lara P, Chansky K, Shibata T, et al.: Cisplatin + irinotecan versus cisplatin + etoposide in extensive stage small cell lung cancer (E-SCLC): Final "common arm": comparative outcomes analysis of JCOG 9511 and SWOG 0124. [Abstract] J Clin Oncol 27 (Suppl 15): A-8027, 2009.


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00045162     History of Changes
Other Study ID Numbers: CDR0000256908, S0124, S0124, S0124, U10CA032102
Study First Received: September 6, 2002
Results First Received: April 16, 2013
Last Updated: July 3, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration