Imatinib Mesylate With or Without Surgery in Treating Patients With Metastatic Gastrointestinal Stromal Tumor That is Responding to Imatinib Mesylate

NCT00956072 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-09-24

No results posted yet for this study

Summary

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.

Conditions

  • Gastrointestinal Stromal Tumor

Interventions

DRUG

imatinib mesylate

Patients receive imatinib mesylate

PROCEDURE

therapeutic conventional surgery

Patients undergo surgery

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Alessandro Gronchi · Istituto Nazionale per lo Studio e la Cura dei Tumori

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00956072 on ClinicalTrials.gov