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Status:

COMPLETED

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

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Collaborating Sponsors:

Italian Sarcoma Group

UNICANCER

Conditions:

Gastrointestinal Stromal Tumor

Eligibility:

All Genders

18-120 years

Phase:

PHASE3

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...

Detailed Description

OBJECTIVES: Primary * Assess whether there is a difference in overall survival between intermediate and high-risk localized GIST patients undergoing complete surgery alone and those undergoing compl...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL (transfusions allowed)
  • Hepatic
  • 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
  • Renal
  • Creatinine \< 1.5 times ULN
  • No uncontrolled chronic renal disease
  • Cardiovascular
  • No New York Heart Association class III-IV cardiac disease
  • No congestive heart failure
  • No myocardial infarction within the past 2 months
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • 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
  • Chemotherapy
  • No prior chemotherapy for gastrointestinal stromal tumors
  • No concurrent anticancer chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radiotherapy
  • No concurrent anticancer radiotherapy
  • Surgery
  • See Disease Characteristics
  • Prior non-curative surgery allowed (e.g., surgery with main diagnostic intent or emergency surgery with symptomatic intent)
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2017

    Estimated Enrollment :

    908 Patients enrolled

    Trial Details

    Trial ID

    NCT00103168

    Start Date

    December 1 2004

    End Date

    September 1 2017

    Last Update

    July 9 2018

    Active Locations (50)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 13 (50 locations)

    1

    Flinders Medical Centre

    Bedford Park, South Australia, Australia, 5042

    2

    Herlev University Hospital

    Herlev, Denmark, DK-2730

    3

    Centre Hospitalier d'Abbeville

    Abbeville, France, 80101

    4

    Centre Paul Papin

    Angers, France, 49036