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Trial record 2 of 20 for:    "dermatofibrosarcoma protuberans"

Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans

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ClinicalTrials.gov Identifier: NCT00243191
Recruitment Status : Completed
First Posted : October 21, 2005
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition: Dermatofibrosarcoma Protuberans
Intervention: Drug: imatinib mesylate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period began May 1, 2006 and was completed July 22, 2009. There were 5 SARC sites participating. SARC sites are primarily academic institutions with Sarcoma programs.

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
Imatinib No text entered.

Participant Flow:   Overall Study
    Imatinib
STARTED   18 
COMPLETED   18 
NOT COMPLETED   0 



  Baseline Characteristics

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
Imatinib No text entered.

Baseline Measures
   Imatinib 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   16 
>=65 years   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (14) 
Gender 
[Units: Participants]
 
Female   10 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures

1.  Primary:   To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies.   [ Time Frame: Prior to and after 2-weeks of imatinib therapy ]


  Serious Adverse Events


  Other Adverse Events


  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
Dermatofibrosarcoma protuberans (DFSP)is a rare tumor type. During the the trial the drug manufacturer obtained approval for DSFP indication.The other limitation is limited funding; SARC is actively seeking funding for secondary outcome goal 12/2012.


  More Information

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 more than 60 days but less than or equal to 180 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: SARC, Chief Operating Officer
Organization: SARC
phone: 734-930-7600
e-mail: sarc@sarctrials.org



Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00243191     History of Changes
Obsolete Identifiers: NCT00176709
Other Study ID Numbers: SARC004
First Submitted: October 20, 2005
First Posted: October 21, 2005
Results First Submitted: March 14, 2011
Results First Posted: March 29, 2012
Last Update Posted: March 29, 2012