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

European Organisation for Research and Treatment of Cancer0 sites908 target enrollmentFebruary 17, 2005

ConditionsGastrointestinal stromal tumors (GIST) are mesenchymal neoplasms usually arising from the gastrointestinal wall. Pathologically,they present with spindle cells in most cases. Immunohistochemically, GIST cells are almost always positive for CD117.CD117 corresponds to the KIT receptor, a tyrosine kinase receptor which is altered in GIST due to a mutation to the c-kit oncogene. This event is held to be critical for GIST pathogenesis.MedDRA version: 14.1 Level: PT Classification code 10051066 Term: Gastrointestinal stromal tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsGLIVEC

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Gastrointestinal stromal tumors (GIST) are mesenchymal neoplasms usually arising from the gastrointestinal wall. Pathologically,they present with spindle cells in most cases. Immunohistochemically, GIST cells are almost always positive for CD117.CD117 corresponds to the KIT receptor, a tyrosine kinase receptor which is altered in GIST due to a mutation to the c-kit oncogene. This event is held to be critical for GIST pathogenesis.
Sponsor: European Organisation for Research and Treatment of Cancer
Enrollment: 908
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 17, 2005

End Date

July 12, 2017

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

European Organisation for Research and Treatment of Cancer

Eligibility Criteria

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)