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

Phase 1

• Conditions: intermediate and high risk localized Gastrointestinal stromal tumors (GIST) patients; MedDRA 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]

• Registration Number: EUCTR2004-001810-16-IT
• Lead Sponsor: ITALIAN SARCOMA GROUP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-11
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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

Study & Design

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