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

• Conditions: advanced gist; MedDRA version: 9.1Level: LLTClassification code 10053548Term: Gastrointestinal cancer metastatic

• Registration Number: EUCTR2007-002257-23-IT
• Lead Sponsor: ITALIAN SARCOMA GROUP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

š Histologically confirmed GIST expressing CD117+, or with
documented mutation of the KIT or PDGFRA gene
š Metastatic disease (liver and/or abdominal cavity); no extra-abdominal
metastases
š Treatment with imatinib administered for 6-12 months, resulting in CR,
PR or SD, without PD since the start of Imatinib therapy (RECIST)
š No prior treatment with imatinib or other tyrosine kinase inhibitors (for
any reason) in the adjuvant or neoadjuvant setting
š Measurable disease (RECIST) before start of imatinib
š Surgically resectable residual disease (assessed on CT scan/ MRI)
š Age ≥ 18 years; performance status 0 to 1 (WHO scale)
š 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

-myocardial infarction, unstable or uncontrolled cardiac disease within 6 months of study
entry
-uncontrolled hypertension (DBP>95 mm Hg; SBP>170 mm Hg)
-history of arterial thrombosis or deep vein thrombosis within 1 year of study entry
- bleeding diathesis, coagulopathy or major bleeding within 6 months of study entry
- coumadin-type anticoagulant > 2mg/day within 7 days of study entry
-major surgery within 28 days of study entry
-prohibited co-medication which interacts moderately or strongly with the CYP3A system
within 14 days of study entry (see detailed list on http://medicine.iupui.edu/flockhart/table.htm),
until both pharmacokinetic samples are taken.
- severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes,
uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis
judged at risk of reactivation, uncontrolled active infection, such as HIV infection, etc.).
- prior malignancy (other than in situ cervical cancer, in situ melanoma, or basal or squamous
cell cancer of the skin) unless treated with curative intent and without evidence of disease for at
least 3 years
špregnancy
- any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions should
be discussed with the patient before randomization in the trial

Study & Design

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