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Clinical Trials/EUCTR2007-002257-23-NL
EUCTR2007-002257-23-NL
Active, not recruiting
Not Applicable

A phase III randomized study evaluating surgery of residual disease in patients withmetastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.

European Organization for Research and Treatment of Cancer0 sites350 target enrollmentOctober 31, 2008
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
European Organization for Research and Treatment of Cancer
Enrollment
350
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 31, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
European Organization for Research and Treatment of Cancer

Eligibility Criteria

Inclusion Criteria

  • •¨ 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)
  • •¨ 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
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •¨ Prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting

Outcomes

Primary Outcomes

Not specified

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