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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00956072 |
Purpose
RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more effective than continued imatinib mesylate in treating patients with metastatic gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying giving imatinib mesylate therapy together with surgery to see how well it works compared with imatinib mesylate alone in treating patients with metastatic gastrointestinal stromal tumor that is responding to imatinib mesylate.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Drug: imatinib mesylate Procedure: therapeutic conventional surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Study Evaluating Surgery of Residual Disease in Patients With Metastatic Gastro-intestinal Stromal Tumor Responding to Imatinib Mesylate. |
| Estimated Enrollment: | 350 |
| Study Start Date: | May 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients undergo surgery of residual disease.
|
Procedure: therapeutic conventional surgery
Patients undergo surgery
|
|
Active Comparator: Arm II
Patients receive imatinib mesylate therapy according to standard of care.
|
Drug: imatinib mesylate
Patients receive imatinib mesylate
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to center, site of tumor origin (stomach vs small bowel vs others), and site of metastases (liver vs abdominal cavity vs both). Patients are randomized to 1 of 2 treatment arms.
Patients complete quality of life questionnaires at baseline; immediately after hospital discharge (arm I only); and at 5, 11, and 23 months. Blood samples may be collected for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 5 years and then every 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Metastatic disease (liver and/or abdominal cavity)
PATIENT CHARACTERISTICS:
No severe and/or uncontrolled concurrent medical disease, including any of the following conditions:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| Italy | |
| European Organization for Research and Treatment of Cancer | |
| Naples, Italy, 80131 | |
| Principal Investigator: | Alessandro Gronchi | Istituto Nazionale per lo Studio e la Cura dei Tumori |
More Information
| ClinicalTrials.gov Identifier: | NCT00956072 History of Changes |
| Other Study ID Numbers: | CDR0000644507, EORTC-62063, EU-20955, EUDRACT-2007-002257-23, NOVARTIS-EORTC-62063 |
| Study First Received: | August 8, 2009 |
| Last Updated: | March 19, 2011 |
| Health Authority: | United States: Federal Government |
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gastrointestinal stromal tumor |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |