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

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ClinicalTrials.gov 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
Information provided by (Responsible Party):

February 7, 2005
February 8, 2005
October 29, 2013
December 2004
October 2008   (Final data collection date for primary outcome measure)
Overall survival
Not Provided
Complete list of historical versions of study NCT00103168 on ClinicalTrials.gov Archive Site
  • Relapse-free survival
  • Relapse-free interval
  • Adverse events
Not Provided
Not Provided
Not Provided
Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor
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

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.



  • 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.

Phase 3
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor
  • Drug: imatinib mesylate
  • Procedure: adjuvant therapy
Not Provided
Casali PG, Le Cesne A, Poveda Velasco A, Kotasek D, Rutkowski P, Hohenberger P, Fumagalli E, Judson IR, Italiano A, Gelderblom H, Adenis A, Hartmann JT, Duffaud F, Goldstein D, Broto JM, Gronchi A, Dei Tos AP, Marréaud S, van der Graaf WT, Zalcberg JR, Litière S, Blay JY. Time to Definitive Failure to the First Tyrosine Kinase Inhibitor in Localized GI Stromal Tumors Treated With Imatinib As an Adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in Collaboration With the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas. J Clin Oncol. 2015 Dec 20;33(36):4276-83. doi: 10.1200/JCO.2015.62.4304. Epub 2015 Nov 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
October 2008   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Denmark,   France,   Germany,   Spain,   United Kingdom
Belgium,   Italy,   Netherlands,   New Zealand,   Poland,   Singapore,   Switzerland
2004-001810-16 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
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
European Organisation for Research and Treatment of Cancer - EORTC
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP