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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
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: None (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
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
No text entered.


  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:
Natale RB, Lara PN, Chansky K, et al.: S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC). [Abstract] J Clin Oncol 26 (Suppl 15): A-7512, 2008.
Hanna NH, Einhorn L, Sandler A, et al.: Randomized, phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated, extensive-stage (ES) small cell lung cancer (SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 23 (Suppl 16): A-LBA7004, 622s, 2005.

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 ( Other Identifier: SWOG )
S0124 ( Other Identifier: NCCTG )
S0124 ( Other Identifier: CALGB )
U10CA032102 ( U.S. NIH Grant/Contract )
Study First Received: September 6, 2002
Results First Received: April 16, 2013
Last Updated: July 3, 2013