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Clinical Trials/ACTRN12609000681257
ACTRN12609000681257
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

European Organisation for Research and Treatment of Cancer (EORTC)0 sites350 target enrollmentAugust 10, 2009
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ConditionsGastro-intestinal stromal tumour (GIST)Cancer - Other cancer types

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Gastro-intestinal stromal tumour (GIST)
Sponsor
European Organisation for Research and Treatment of Cancer (EORTC)
Enrollment
350
Status
Not yet recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 10, 2009
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •Histologically confirmed gastro\-intestinal stromal tumour (GIST).
  • •\- Metastatic disease (liver and/or abdominal cavity)
  • •\- Treatment with imatinib mesylate for 6 \- 12 months either as standard care or within other clinical studies.
  • •\- Progression not experienced on imatinib.
  • •\- Surgically resectable disease.

Exclusion Criteria

  • •\- Previous treatment with imatinib or other tyrosince kinase inhibitor (TKI) other than treatment with imatinib in the past 6 \- 12 months.
  • •\- Extra\-abdominal matastases
  • •\- Myocardial infarction, unstable or uncontrolled cardiac disease within 6 months prior to study entry
  • •\- Coumarin\-type anticoagulant \>2mg/day within 7 days prior to study entry
  • •\- Pregnancy/breastfeeding

Outcomes

Primary Outcomes

Not specified

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