Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Walther Cancer Institute
Information provided by (Responsible Party):
Nasser Hanna, M.D., Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00319735
First received: April 27, 2006
Last updated: March 28, 2016
Last verified: March 2016
Results First Received: January 11, 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: Procedure: Radiation Therapy
Procedure: Surgery
Procedure: Tissue Sample

  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
No text entered.

Reporting Groups
  Description
Single Arm Assignment

Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36

Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks

Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy

Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission


Participant Flow:   Overall Study
    Single Arm Assignment  
STARTED     41  
COMPLETED     39  
NOT COMPLETED     2  
Death                 2  



  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.
No text entered.

Reporting Groups
  Description
Single Arm Assignment

Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36

Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks

Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy

Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission


Baseline Measures
    Single Arm Assignment  
Number of Participants  
[units: participants]
  41  
Age, Customized  
[units: years]
Median (Full Range)
 
Median     64  
  (50 to 82)  
Gender  
[units: participants]
 
Female     3  
Male     38  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     37  
Unknown or Not Reported     2  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     36  
More than one race     0  
Unknown or Not Reported     1  
Tumor Site  
[units: participants]
 
Esophagus     26  
Gastroesophageal Junction     15  
Disease Stage [1]
[units: participants]
 
IIA     10  
IIB     7  
III     22  
IVA     2  
Histology  
[units: participants]
 
Squamous cell carcinoma     9  
Adenocarcinoma     32  
Eastern Cooperative Oncology Group (ECOG) Performance Status [2]
[units: participants]
 
0     26  
1     13  
2     2  
[1]

Stage I, Stage II, and Stage III Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues.

Stage IV The cancer has spread to distant parts of the body.

[2] Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead:



  Outcome Measures
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1.  Primary:   Complete Pathologic Response (pCR)   [ Time Frame: 36 months ]

2.  Secondary:   Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.   [ Time Frame: Up to 36 months ]

3.  Secondary:   Time to Relief of Dysphagia   [ Time Frame: 36 months ]

4.  Secondary:   Evaluate Toxicity   [ Time Frame: 36 months ]

5.  Secondary:   Perform Exploratory Molecular Correlates.   [ Time Frame: 36 months ]

6.  Secondary:   Complete and Partial Response Rate for Patients by Disease Stage: IIA   [ Time Frame: 36 months ]

7.  Secondary:   Complete and Partial Response Rate for Patients by Disease Stage: IIB   [ Time Frame: 36 months ]

8.  Secondary:   Complete and Partial Response Rate for Patients by Disease Stage: III   [ Time Frame: 36 months ]

9.  Secondary:   Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma   [ Time Frame: 36 months ]

10.  Secondary:   Complete and Partial Response Rate for Patients by Histology: Squamous Cell   [ Time Frame: 36 months ]


  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: Principal Investigator
Organization: Hoosier Cancer Research Network, Inc.
phone: 317-921-2050
e-mail: jsmith@hoosiercancer.org


Publications of Results:

Responsible Party: Nasser Hanna, M.D., Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00319735     History of Changes
Other Study ID Numbers: HOG GI05-92
Study First Received: April 27, 2006
Results First Received: January 11, 2016
Last Updated: March 28, 2016
Health Authority: United States: Institutional Review Board