EUCTR2004-001810-16-IT
Active, not recruiting
Phase 1
Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no furthrer therapy complete surgery. - EORTC 62024
Conditionsintermediate and high risk localized Gastrointestinal stromal tumors (GIST) patientsMedDRA version: 14.1Level: PTClassification code 10051066Term: Gastrointestinal stromal tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsGLIVEC*120CPS 100MG
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- intermediate and high risk localized Gastrointestinal stromal tumors (GIST) patients
- Sponsor
- ITALIAN SARCOMA GROUP
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven diagnosis of GIST\-Intermediate\-high risk of relapse\- Surgery performed from 2 weeks to 3 months before randomization\- Non evidence of residual macroscopic disease after surgery\-No prior radiation therapy, no prior chemotherapy for GIST, no prior Imatinib mesylate or any molecolar targeted or biological therapy\-Absence of distant metastases including absence of any peritoneal lesion not contiguous to the primary tumor\-Age \>/\= 18\- WHO PS \=0\-2\-No class 3/4 cardiac problems\- No severe/uncontrolled concurrent medical desease\-No prior or ongoing other malignancy, exept adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent for which the patient has been continuously disease free for at least 5 years\- Adequated liver function (serum bilirubin \= 1\.5xIULN,AST or ALT \= 2\.5IULN)\-Adequated renal function (serum creatinin \< 1\.5 xIULN\-ANC \>/\=1\.5 x109/l\-platelet count \>/\=100x109/l\-baseline Hemoglobin \>/\=9g/dl\-Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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 radiation therapy, prior chemotherapy for GIST, prior Imatinib mesylate or any molecolar targeted or biological therapy\-Distant metastases including peritoneal lesion not contiguous to the primary tumor\-severe/uncontrolled concurrent medical desease\-Ongoing pregnancy or nursing\-Use of coumarine derivatives at the time of treatment start\-Unadequated liver or renal function\- Any psychological, familial, sociological, condition potentially hampering compliance with the study protocol and follow up
Outcomes
Primary Outcomes
Not specified
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Completed
Phase 3
Adjuvant GIST TrialACTRN12605000712606AGITG400