A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to imatinib mesylate
Phase 3
- Conditions
- Gastro-intestinal stromal tumour (GIST)Cancer - Other cancer types
- Registration Number
- ACTRN12609000681257
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 350
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival, defined according to the RECIST criteria for tumour response.[For patients randomised to receive surgery:<br>One month after surgery, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression. <br>For patient randomised to the control arm (no surgery):<br>Two months after randomisation, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.]
- Secondary Outcome Measures
Name Time Method