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Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00802880
First received: December 4, 2008
Last updated: December 20, 2016
Last verified: December 2016
Results First Received: June 16, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sarcoma
Intervention: Drug: Dacarbazine

  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
The study opened to accrual on 03/16/2009 and closed to accrual on 12/15/2014.

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
Dacarbazine Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.

Participant Flow:   Overall Study
    Dacarbazine
STARTED   80 
COMPLETED   80 
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.
No text entered.

Reporting Groups
  Description
Dacarbazine Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.

Baseline Measures
   Dacarbazine 
Overall Participants Analyzed 
[Units: Participants]
 80 
Age 
[Units: Years]
Median (Full Range)
 53 
 (20 to 82) 
Gender 
[Units: Participants]
Count of Participants
 
Female      40  50.0% 
Male      40  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   80 


  Outcome Measures
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1.  Primary:   Best Anatomical Tumor Response   [ Time Frame: After completion of 3 cycles ]

2.  Secondary:   Rate of Neutropenia (Grade 3/4)   [ Time Frame: Completion of 6 cycles of treatment (18 weeks) ]

3.  Secondary:   Rate of Nausea/Emesis (Any Grade)   [ Time Frame: Completion of 6 cycles of treatment (18 weeks) ]

4.  Secondary:   Comparison of the SUV at up to 3 Tumor Sites   [ Time Frame: Baseline and after every three cycles of treatment (up to 1 year) ]

5.  Secondary:   Overall Tumor Metabolic Response   [ Time Frame: After completion of 3 cycles ]

6.  Secondary:   Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate   [ Time Frame: After completion of 3 cycles ]

7.  Secondary:   Overall Disease Control Rate   [ Time Frame: 12 months ]

8.  Secondary:   Time to Progression (TTP)   [ Time Frame: Until completion of follow-up (estimated to be 1 year) ]

9.  Secondary:   Overall Survival   [ Time Frame: Until completion of follow-up or patient death (estimated to be 1 year) ]

10.  Secondary:   Correlate the Time to Progression With Best Anatomic Response   [ Time Frame: Completion of follow-up (estimated to be 1 year) ]

11.  Secondary:   Correlate Time to Progression With Best Metabolic Response   [ Time Frame: Completion of follow-up (estimated to be 1 year) ]

12.  Secondary:   Correlate Overall Survival With Best Anatomic Response   [ Time Frame: Completion of follow-up (estimated to be 1 year) ]

13.  Secondary:   Correlate Overall Survival With Best Metabolic Response   [ Time Frame: Completion of follow-up (estimated to be 1 year) ]


  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: Brian Van Tine, M.D., Ph.D.
Organization: Washington University School of Medicine
phone: 314-362-5817
e-mail: bvantine@dom.wustl.edu


Publications:


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00802880     History of Changes
Other Study ID Numbers: 08-1299 / 201109179
Study First Received: December 4, 2008
Results First Received: June 16, 2016
Last Updated: December 20, 2016