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Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer

This study has been terminated.
(OncoGel did not show any impact on overall tumor response)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573131
First Posted: December 13, 2007
Last Update Posted: February 9, 2016
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.
Information provided by (Responsible Party):
BTG International Inc.
Results First Submitted: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Esophageal Cancer
Adenocarcinoma of the Esophagus
Squamous Cell Carcinoma
Interventions: Drug: OncoGel (Paclitaxel gel)
Drug: cisplatin
Drug: 5-FU
Radiation: radiation therapy
Procedure: esophageal resection

  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
Patients were enrolled from 21 Jan 2008 through 05 Nov 2010 at 20 centers in 5 countries (United States, India, Poland, Czech Republic and Belgium).

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
Group 1 OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Group 2 Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.

Participant Flow:   Overall Study
    Group 1   Group 2
STARTED   72   65 
COMPLETED   62   57 
NOT COMPLETED   10   8 
Withdrawal by Subject                10                8 



  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
Group 1 OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Group 2 Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 72   65   137 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   55   48   103 
>=65 years   17   17   34 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.4  (7.2)   57.6  (10.9)   58.0  (9.1) 
Gender 
[Units: Participants]
     
Female   19   21   40 
Male   53   44   97 
Region of Enrollment 
[Units: Participants]
     
United States   13   9   22 
Czech Republic   14   11   25 
Poland   8   9   17 
Belgium   0   1   1 
India   37   35   72 


  Outcome Measures

1.  Primary:   Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT   [ Time Frame: Screening and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Study prematurely terminated due to lack of efficacy in primary endpoint.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Manager Biostatistics
Organization: BTG International
phone: 801-556-8882
e-mail: claire.daugherty@btgplc.com



Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00573131     History of Changes
Other Study ID Numbers: PR016-CLN-pro003
First Submitted: December 11, 2007
First Posted: December 13, 2007
Results First Submitted: April 17, 2014
Results First Posted: May 16, 2014
Last Update Posted: February 9, 2016