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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00573131
First received: December 11, 2007
Last updated: April 17, 2014
Last verified: April 2014
Results First Received: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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
None

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  
Number of Participants  
[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
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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
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


No publications provided


Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00573131     History of Changes
Other Study ID Numbers: PR016-CLN-pro003
Study First Received: December 11, 2007
Results First Received: April 17, 2014
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
India: Drugs Controller General of India
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products