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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109850
Recruitment Status : Terminated (Closed due to poor accrual)
First Posted : May 4, 2005
Results First Posted : August 23, 2012
Last Update Posted : November 18, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Esophageal Cancer
Interventions: Biological: cetuximab
Drug: cisplatin
Drug: irinotecan hydrochloride
Radiation: radiation therapy

  Participant Flow

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

Participant Flow:   Overall Study
Eligible   21 
Eligible and Began Protocol Therapy   21 
Adverse Event                1 
Death                2 
Ineligible                1 

  Baseline Characteristics

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (43.0 to 83.1) 
[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

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

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

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

Responsible Party: Southwest Oncology Group Identifier: NCT00109850     History of Changes
Other Study ID Numbers: CDR0000426442
S0414 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: May 3, 2005
First Posted: May 4, 2005
Results First Submitted: June 14, 2012
Results First Posted: August 23, 2012
Last Update Posted: November 18, 2015