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Clinical Trial Listing
Trial Name:

Z 9001
Intro: A Phase III Randomized Double-blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)
Condition:
Description: This study will ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer survivals compared to the patients randomized to the Placebo Arm. Patients will be randomized to receive oral daily dose of STI571 or matching placebo for one year. Therapy must be initiated prior to 84 days from surgery. A patient receiving placebo may crossover to STI571 upon tumor recurrence.
Criteria:
  1. Patients must have a histologic diagnosis of primary GIST that expresses Kit protein by immunohistochemistry and have tumor size of greater than or equal to 3 cm in maximum dimension
  2. Patients must be at least 18 years of age
  3. Patients must have undergone complete gross resection of a primary GIST within 70 days prior to registration
  4. Patients must have adequate bone marrow, kidney and liver function.
Contact: For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422

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All information regarding participation in Clinical Trials is treated with the utmost confidentiality. University Hospitals Case Medical Center and the Division of Clinical Research recognize and respect the confidentiality of this information. Access to information related to clinical trials and their participants is restricted to authorized clinical trials personnel only.

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