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Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00176800
First received: September 12, 2005
Last updated: July 12, 2016
Last verified: July 2016
Results First Received: April 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 Carcinoma
Interventions: Drug: Tetrathiomolybdate (TM)
Procedure: Radiation
Procedure: Surgery

  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
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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
  Description
Chemoradiation and Tetrathiomolybdate (TM)

Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.

Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.

Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.


Participant Flow:   Overall Study
    Chemoradiation and Tetrathiomolybdate (TM)  
STARTED     69  
COMPLETED     69  
NOT COMPLETED     0  



  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
Chemoradiation and Tetrathiomolybdate (TM)

Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.

Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.

Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.


Baseline Measures
    Chemoradiation and Tetrathiomolybdate (TM)  
Number of Participants  
[units: participants]
  69  
Age  
[units: years]
Median (Full Range)
  60  
  (42 to 74)  
Gender  
[units: participants]
 
Female     67  
Male     2  



  Outcome Measures
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1.  Primary:   Median Recurrence Free Survival Time   [ Time Frame: 8 years ]

2.  Secondary:   Median Overall Survival Time   [ Time Frame: 8 years ]

3.  Secondary:   Percentage of Patients That Require Dose Modification Due to Toxicity   [ Time Frame: 8 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. Susan Urba, M.D.
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-615-4762
e-mail: surba@umich.edu



Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00176800     History of Changes
Other Study ID Numbers: UMCC 2001-007
HUM 49005 Legacy 2001-0623 ( Other Identifier: University of Michigan IRBMED )
Study First Received: September 12, 2005
Results First Received: April 14, 2016
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration