TRIAL DETAIL
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery (Z9000)
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Trial Name: |
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery (Z9000) |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Completed |
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Phase: |
2 |
Start Date 09/27/2001 |
Age of Trial (yrs) 21.5 |
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Treatment Phase: |
Adjuvant |
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Drug Category: |
KIT/PDGFRA inhibitor |
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Strategy: |
Block KIT |
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Trial Type: |
Specifically GIST and only GIST |
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Other Protocol IDs: |
CDR0000068942, ACOSOG-Z9000, CWRU-020313 |
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Sponsor: |
ACS
NCI |
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Patient Contact: |
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Randomized: |
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IV or Oral: |
Oral |
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Trial Notes: |
This phase II trial (Z9000) of adjuvant Gleevec enrolled 106 patients beginning in September, 2001. The trial is ongoing but not recruiting new patients. Patients were given Gleevec for one year and then followed. This trial has some of the longest follow-up of the adjuvant trials and thus some of the better data on what happens to patients after they stop taking imatinib. The Z9001 phase III adjuvant trial had a placebo so it demonstrates the large advantage that Gleevec has in preventing (or delaying) a recurrence; however the follow-up time is not as long. See the links under trial results. |
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Trial Results |
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