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 further therapy after complete surgery

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 908

Inclusion Criteria

? Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117)
? Risk of relapse documented on the surgical specimen, according to the 2002 Consensus Approach to Diagnosis of GIST (See Appendix H and Ref. 7), as falling within the high-risk” category (tumor size >10 cm; or mitotic rate >10/50HPF; or tumor size >5 cm & mitotic rate >5/50HPF) or the intermediate-risk” category (tumor size <5 cm & mitotic rate 6-10/50HPF; or tumor size 5-10 cm & mitotic rate <5/50HPF).
? Surgery performed from 2 weeks to 3 months before randomization (patients randomized in the treated arm should start Imatinib mesylate within 3 months of surgery).
? Non evidence of residual macroscopic disease after surgery. Patients with R0 or R1 resection are eligible.
? Prior surgery is admitted provided it was devoid of eradicative intent (e.g., surgery with a main diagnostic intent, emergency surgery with a symptomatic intent, etc.)
? No prior radiation therapy, no prior chemotherapy for GIST, no prior therapy with Imatinib mesylate, or any other molecular targeted or biological therapy.
? Absence of distant metastases, including absence of any peritoneal lesion not contiguous to the primary tumor, while regional positive lymph nodes are admitted provided they have been macroscopically excised.
? Age >18 yrs.
? WHO PS = 0-2 (see Appendix B)
? The cardiac ejection function will be assessed at baseline. The choice of the method is left to physician’s discretion (LVEF (MUGA or ECHO), NT-proBNP….). An ECG must also be performed. No Class 3/4 cardiac problems, as defined by the New York Heart Association Criteria (e.g., congestive heart failure, myocardial infarction within 2 months of study; see Appendix C)
? Absence of 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.).
? No prior, or ongoing other malignancy, except 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 >5 years.
? No ongoing pregnancy or nursing. Women/men of reproductive potential must agree to use an effective contraceptive method throughout the treatment period and for up to 3 months following discontinuation of the drug. Women of reproductive potential must have a negative pregnancy test within 7 days prior to treatment start.
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

Not provided

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials