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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103168
Recruitment Status : Unknown
Verified October 2013 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was:  Active, not recruiting
First Posted : February 8, 2005
Last Update Posted : October 29, 2013
Italian Sarcoma Group
Grupo Espanol de Investigacion en Sarcomas
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor Drug: imatinib mesylate Procedure: adjuvant therapy Phase 3

Detailed Description:



  • Compare imatinib monotherapy failure free survival of patients in the two regimens.


  • Compare relapse-free survival,relapse-free interval and overall survival in patients treated with these regimens.
  • Determine the safety of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, risk category (high vs intermediate), tumor site (gastric vs other), and resection level (R0 vs R1). Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive adjuvant oral imatinib mesylate once daily for 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients are observed (without receiving further antitumoral therapy) every 3 months for 2 years.

After completion of study treatment, patients in arm I are followed every 3 months for 2 years. All patients are then followed every 4 months for 3 years and at least annually thereafter.

PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study within 5 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermediate and High Risk Localized, Completely Resected, Gastrointestinal Stromal Tumors (GIST) Expressing KIT Receptor: A Controlled Randomized Trial on Adjuvant Imatinib Mesylate (Glivec) Versus No Further Therapy After Complete Surgery
Study Start Date : December 2004
Primary Completion Date : October 2008

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Relapse-free survival
  2. Relapse-free interval
  3. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed gastrointestinal stromal tumor

    • Localized disease
  • Meets 1 of the following criteria:

    • At high-risk of relapse, defined by 1 of the following criteria:

      • Tumor size > 10 cm
      • Mitotic rate > 10/50 high-power field (HPF)
      • Tumor size > 5 cm AND mitotic rate > 5/50 HPF
    • At intermediate-risk of relapse, defined by 1 of the following criteria:

      • Tumor size < 5 cm AND mitotic rate 6-10/50 HPF
      • Tumor size 5-10 cm AND mitotic rate < 5/50 HPF
  • Tumor must stain positive for Kit (CD117) by polyclonal DAKO antibody staining
  • Must have undergone complete resection of the primary tumor at least 2 weeks, but no more than 3 months, before study entry

    • Meets criteria for 1 of the following resection levels:

      • R0 (clear margins)
      • R1, defined by 1 of the following criteria:

        • Margins of resection are contaminated by tumor, but no macroscopic tumor is left behind
        • Intraoperative tumor rupture
        • Shelling-out procedure
        • Endoscopic maneuver
    • No residual macroscopic disease after surgery

      • Regional positive lymph nodes allowed provided they have been macroscopically excised
  • No distant metastases*, including any of the following:

    • Peritoneal lesion not contiguous to the primary tumor
    • Liver metastases
    • Hemoperitoneal metastases NOTE: *Even if a complete resection (R0) was performed



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (transfusions allowed)


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 times ULN
  • No uncontrolled liver disease
  • No chronic viral hepatitis at risk of reactivation


  • Creatinine < 1.5 times ULN
  • No uncontrolled chronic renal disease


  • No New York Heart Association class III-IV cardiac disease
  • No congestive heart failure
  • No myocardial infarction within the past 2 months


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 3 months after study participation
  • No uncontrolled diabetes
  • No uncontrolled active infection
  • No HIV infection
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance or participation
  • No other severe and/or uncontrolled medical disease
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy

  • No other prior molecular targeted or biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) to support blood counts
  • No concurrent anticancer biologic agents


  • No prior chemotherapy for gastrointestinal stromal tumors
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy
  • No concurrent anticancer radiotherapy


  • See Disease Characteristics
  • Prior non-curative surgery allowed (e.g., surgery with main diagnostic intent or emergency surgery with symptomatic intent)


  • No prior imatinib mesylate
  • No prior randomization to this study
  • No concurrent therapeutic anticoagulation with coumarin derivatives

    • Concurrent therapeutic low-molecular weight heparin or mini-dose coumarin derivatives (equivalent to oral warfarin 1 mg/day) allowed for prophylaxis of central venous catheter thrombosis
  • No other concurrent antitumoral therapy
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103168

  Hide Study Locations
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Herlev University Hospital
Herlev, Denmark, DK-2730
Centre Hospitalier d'Abbeville
Abbeville, France, 80101
Centre Paul Papin
Angers, France, 49036
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Hopital Avicenne
Bobigny, France, 93009
Institut Bergonie
Bordeaux, France, 33076
Hopital Ambroise Pare
Boulogne Billancourt, France, 92100
C.H.U. de Brest
Brest, France, 29200
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Hopital Louis Pasteur
Colmar, France, 68024
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre Hospitalier de Dreux
Dreux, France, 28100
Hopital Andre Mignot
Le Chesnay, France, 78157
C. H. Du Mans
Le Mans, France, 72037
Hopital Robert Boulin
Libourne, France, 33500
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
Hopital Edouard Herriot - Lyon
Lyon, France, 69437
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
CHU de la Timone
Marseille, France, 13385
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, France, 40000
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
CHR Hotel Dieu
Nantes, France, 44093
CHR D'Orleans - Hopital de la Source
Orleans, France, 45100
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Saint Antoine
Paris, France, 75571
Hopital Cochin
Paris, France, 75674
Hopital Tenon
Paris, France, 75970
Centre Hospitalier - Pau
Pau, France, 64046
CHU - Robert Debre
Reims, France, 51092
Centre Hospitalier Universitaire de Rennes
Rennes, France, 35033
Centre Eugene Marquis
Rennes, France, 35064
Hopital Charles Nicolle
Rouen, France, 76031
Centre Henri Becquerel
Rouen, France, 76038
Centre Rene Huguenin
Saint Cloud, France, 92210
Institut de Cancerologie de la Loire
Saint Priest en Jarez, France, 42270
Centre Paul Strauss
Strasbourg, France, 67065
Hopital Universitaire Hautepierre
Strasbourg, France, 67098
Institut Claudius Regaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Southwest German Cancer Center at Eberhard-Karls-University
Tuebingen, Germany, D-72076
Complejo Hospitalario de Leon
Leon, Spain, 24008
Grupo Espanol de Investigacion del Cancer de Mama
Madrid, Spain, 28700
United Kingdom
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom, G12 0YN
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Italian Sarcoma Group
Grupo Espanol de Investigacion en Sarcomas
Study Chair: Paolo G. Casali, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Chair: Axel Le Cesne, MD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Andres Poveda, MD Instituto Valenciano De Oncologia

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00103168     History of Changes
Other Study ID Numbers: EORTC-62024
2004-001810-16 ( EudraCT Number )
First Posted: February 8, 2005    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
gastrointestinal stromal tumor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action