Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
American College of Radiology Imaging Network
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00028002
First received: December 7, 2001
Last updated: May 7, 2014
Last verified: November 2012
Results First Received: November 29, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Interventions: Drug: imatinib mesylate
Procedure: conventional 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
No text entered.

Reporting Groups
  Description
Imatinib Mesylate Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

Participant Flow:   Overall Study
    Imatinib Mesylate  
STARTED     63  
COMPLETED     52 [1]
NOT COMPLETED     11  
Withdrawal by Subject                 3  
Ineligible                 8  
[1] Subjects comtributing data to the primary analysis are considered to have completed the study.



  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
Imatinib Mesylate Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

Baseline Measures
    Imatinib Mesylate  
Number of Participants  
[units: participants]
  52  
Age  
[units: years]
Median ( Full Range )
  58.5  
  ( 24.0 to 84.0 )  
Gender  
[units: participants]
 
Female     24  
Male     28  



  Outcome Measures

1.  Primary:   Rate of Disease Progression at 2 Years   [ Time Frame: From registration to two years ]

2.  Primary:   Rates of Objective Response (Complete, Partial, and Stable)   [ Time Frame: Up to 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Primary:   Incidence of Adverse Events Grade 3 or Greater Graded According to NCI Common Toxicity Criteria (CTC) Version 2.0 (i.e., Major Toxicity)   [ Time Frame: Up to 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Primary:   Change in Biological Markers of Imatinib Mesylate, Including C-kit and Tyrosine   [ Time Frame: to be entered ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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:  
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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group
e-mail: wseiferheld@acr.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028002     History of Changes
Other Study ID Numbers: NCI-2012-02437, NCI-2012-02437, ECOG-RTOG-R0132, RTOG-DEV-1055, ACRIN-6665, CDR0000069111, RTOG-S-0132, RTOG-0132, RTOG-0132, U10CA021661
Study First Received: December 7, 2001
Results First Received: November 29, 2012
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration