A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.
- Conditions
- bowel wall cancer10017990GIST10017998
- Registration Number
- NL-OMON32805
- Lead Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
* Histologically confirmed GIST expressing CD117+, or with documented mutation of
the KIT or PDGFRA gene
* Metastatic disease (liver and/or abdominal cavity); no extra-abdominal
metastases
* Treatment with Imatinib administered for 6-12 months, resulting in CR,
PR or SD, without PD since the start of Imatinib therapy (RECIST)
* No previous treatment with Imatinib or other tyrosine kinase inhibitors (for
whatever reason) in the adjuvant of neoadjuvant setting
* Measurable disease (RECIST) before start of Imatinib
* Surgically resectable residual disease (assessed on CT scan/ MRI)
* Age >= 18 years; performance status 0 to 1 (WHO scale)
* Adequate hematologic and organ function
* Prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival, measured from the date of randomization for surgery. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival, measured from the date of randomization for surgery.<br /><br>Overall and progression free survival, measured from the start of Imatinib<br /><br>therapy, will also be reported for the two therapeutics arms; however, this<br /><br>analysis will be descriptive only.<br /><br>In the surgery arm, pathological response to Imatinib will be assessed; the<br /><br>rate of complete resection and the surgical morbididy will also be reported.<br /><br>Quality of life.</p><br>