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Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176800
First Posted: September 15, 2005
Last Update Posted: August 22, 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):
University of Michigan Cancer Center
Results First Submitted: April 14, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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
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) 
Overall Participants Analyzed 
[Units: Participants]
 69 
Age 
[Units: Years]
Median (Full Range)
 60 
 (42 to 74) 
Gender 
[Units: Participants]
 
Female   67 
Male   2 


  Outcome Measures
  Show All Outcome Measures

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 )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: April 14, 2016
Results First Posted: August 22, 2016
Last Update Posted: August 22, 2016