Tumor Clinical Trial
Official title:
Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.
Gastrointestinal stromal tumor (GIST) is a rare cancer affecting primarily the digestive
tract and sometimes abdominal cavity in adults. The most common site is the stomach followed
by the duodenum and small intestine.
Surgery is the mainstay of therapy for GIST patients whose primary tumor is felt to be
resectable. Prior to the introduction of Gleevec, patients with inoperable GIST had
essentially no therapeutic options. However, sunitinib trials offer options to patients who
are Gleevec resistant or have intolerant GIST. Clinical benefit has been demonstrated with
positive results in several sunitinib studies of varying phases.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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