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NCT00041197 · ClinicalTrials.gov registry record · Phase 3

Imatinib Mesylate in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed By Surgery

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
732
Enrollment target

NCT00041197: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00041197 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 732 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00041197, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
732 participants
Enrollment target

Study Summary

This randomized phase III trial is studying imatinib mesylate to see how well it works compared to placebo in treating patients with primary gastrointestinal stromal tumor that has been completely removed by surgery. Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for patients with primary gastrointestinal stromal tumor that has been completely removed by surgery.

Primary Outcome

An O'Brien-Fleming bound will be used to stop the trial early for superiority of the STI571 arm.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER placebo
  • DRUG imatinib mesylate

Trial Details

FieldValue
Enrollment Target 732 participants
Start Date 2002-06
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00041197 record still lists

NCT00041197 is an interventional study that assigns participants to a tested intervention. The registered 732 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT00041197 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00041197 about?

NCT00041197 is a clinical study titled "Imatinib Mesylate in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed By Surgery". This randomized phase III trial is studying imatinib mesylate to see how well it works compared to placebo in treating patients with primary gastrointestinal stromal tumor that has been completely removed by surgery. Imatinib mesylate may interfere with the growth of tumor cells and may be an effect...

What is the current status of trial NCT00041197?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 732 participants. The study started on 2002-06.

What interventions are being tested in trial NCT00041197?

The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), imatinib mesylate (DRUG).

Who is sponsoring clinical trial NCT00041197?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00041197's enrollment target sits among peer trials

732 485th of 2000 higher than 1,513 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00041197, the US trial registry maintained by the National Library of Medicine. NCT00041197 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.