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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002257-23-NL

Enrollment

350

Registered

2008-10-31

Start date

2009-01-26

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic gastro-intestinal stromal tumor MedDRA version: 9.1 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor

Interventions

Product Name: Imatinib Pharmaceutical Form: Other descriptive name: IMATINIB MESILATE

Eligibility

Sex/Gender

All

Inclusion 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether surgery of residual disease in patients with advanced GIST responding to imatinib improves the progression free survival.;Secondary Objective: To correlate the pharmacokinetics of imatinib and its metabolites in both the experimental (surgery) and standard (non-surgery) treatment arms, with the pharmacokinetics of imatinib and metabolites preceding randomisation.;Primary end point(s): The primary end-point is progression free survival, measured from the date of randomization for surgery.	—

Measure

Time frame

Main Objective: To evaluate whether surgery of residual disease in patients with advanced GIST responding to imatinib improves the progression free survival.;Secondary Objective: To correlate the pharmacokinetics of imatinib and its metabolites in both the experimental (surgery) and standard (non-surgery) treatment arms, with the pharmacokinetics of imatinib and metabolites preceding randomisation.;Primary end point(s): The primary end-point is progression free survival, measured from the date of randomization for surgery.

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Countries

France, Italy, Netherlands, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026