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Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor

NCT00103168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 908

Last updated 2018-07-09

No results posted yet for this study

Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor.

PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor.

Conditions

  • Gastrointestinal Stromal Tumor

Interventions

DRUG

imatinib mesylate

400 mg/day for 2 years

Sponsors & Collaborators

  • Italian Sarcoma Group

    collaborator NETWORK

  • UNICANCER

    collaborator OTHER

  • Grupo Espanol de Investigacion en Sarcomas

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Paolo G. Casali, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  • Axel Le Cesne, MD · Gustave Roussy, Cancer Campus, Grand Paris

  • Andres Poveda, MD · Instituto Valenciano De Oncologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-10-31
Completion
2017-09-30

Countries

  • Australia
  • Denmark
  • France
  • Germany
  • Spain
  • United Kingdom

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 NCT00103168 on ClinicalTrials.gov