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Clinical Trials/NL-OMON32805
NL-OMON32805
Not yet recruiting
Phase 3

A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate. - De rol van chirurgie bij gemetastaseerd gastro-intestinale stromatumoren.

European Organisation for Research in Treatment of Cancer (EORTC)0 sites60 target enrollmentStarted: TBDLast updated:
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Conditionsbowel wall cancerGIST1001799010017998

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)
Enrollment
60
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

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
  • •\* 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)

Exclusion Criteria

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

Investigators

Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)

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