Irinotecan, Cisplatin, Bevacizumab, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00354679
First received: July 19, 2006
Last updated: April 12, 2016
Last verified: April 2016
Results First Received: January 14, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Esophageal Cancer
Interventions: Biological: bevacizumab
Drug: cisplatin
Drug: irinotecan hydrochloride
Genetic: proteomic profiling
Other: diagnostic laboratory biomarker analysis
Other: mass spectrometry
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
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
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma

Participant Flow:   Overall Study
    Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger  
STARTED     34  
COMPLETED     33  
NOT COMPLETED     1  
Patient Not Treated                 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
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma

Baseline Measures
    Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger  
Number of Participants  
[units: participants]
  34  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     31  
>=65 years     3  
Gender  
[units: participants]
 
Female     7  
Male     27  



  Outcome Measures

1.  Primary:   Evaluation of Safety and Toxicity   [ Time Frame: 2 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. David Ilson
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4183
e-mail: ilsond@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00354679     History of Changes
Other Study ID Numbers: 06-013
P30CA008748 ( US NIH Grant/Contract Award Number )
MSKCC-06013
Study First Received: July 19, 2006
Results First Received: January 14, 2016
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board