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

Phase 1

• Conditions: Metastatic gastro-intestinal stromal tumor; MedDRA version: 9.1Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumor

• Registration Number: EUCTR2007-002257-23-FR
• Lead Sponsor: European Organization for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-03
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.