S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

This study has been terminated.
(Closed due to poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00109850
First received: May 3, 2005
Last updated: July 20, 2012
Last verified: July 2012
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Esophageal Cancer
Interventions: Biological: cetuximab
Drug: cisplatin
Drug: irinotecan hydrochloride
Radiation: radiation therapy

  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
Treatment Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3

Participant Flow:   Overall Study
    Treatment  
STARTED     22  
Eligible     21  
Eligible and Began Protocol Therapy     21  
COMPLETED     18  
NOT COMPLETED     4  
Adverse Event                 1  
Death                 2  
Ineligible                 1  



  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.
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Reporting Groups
  Description
Treatment Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3

Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Median ( Full Range )
  61.4  
  ( 43.0 to 83.1 )  
Gender  
[units: participants]
 
Female     6  
Male     15  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     20  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     15  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Overall Survival at 2 Years   [ Time Frame: 0-2 years ]

2.  Secondary:   Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Patients were assessed for adverse events after every two cycles of chemotherapy. ]

3.  Secondary:   Objective Response (Confirmed and Unconfined, Complete and Partial)   [ Time Frame: at week 16, then every 3 months until progression ]

4.  Secondary:   Progression Free Survival   [ Time Frame: 0 - 5 years ]


  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: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


No publications provided


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00109850     History of Changes
Other Study ID Numbers: CDR0000426442, S0414, U10CA032102
Study First Received: May 3, 2005
Results First Received: June 14, 2012
Last Updated: July 20, 2012
Health Authority: United States: Federal Government