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NCT00103168 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2018-07-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    400 mg/day for 2 years
    intervention Names
    1. Drug: imatinib mesylate
    label
    Imatinib mesylate
    type
    EXPERIMENTAL
  2. label
    Control
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. Imatinib mesylate
    description
    400 mg/day for 2 years
    name
    imatinib mesylate
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
908
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
secondary Outcomes
  1. measure
    Relapse-free survival
  2. measure
    Relapse-free interval
  3. measure
    Adverse events
Full study description
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.
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 complete surgery plus adjuvant imatinib mesylate 400 mg daily for two years Secondary * Assess whether there is a difference in relapse-free survival and relapse-free interval between GIST undergoing complete surgery alone and those undergoing surgery + adjuvant Imatinib mesylate 400 mg daily for two years. * 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). * 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 900 patients will be accrued for this study within 3.5 years.
Source references
references
  1. citation
    Gronchi A, Bonvalot S, Poveda Velasco A, Kotasek D, Rutkowski P, Hohenberger P, Fumagalli E, Judson IR, Italiano A, Gelderblom HJ, van Coevorden F, Penel N, Kopp HG, Duffaud F, Goldstein D, Broto JM, Wardelmann E, Marreaud S, Smithers M, Le Cesne A, Zaffaroni F, Litiere S, Blay JY, Casali PG. Quality of Surgery and Outcome in Localized Gastrointestinal Stromal Tumors Treated Within an International Intergroup Randomized Clinical Trial of Adjuvant Imatinib. JAMA Surg. 2020 Jun 1;155(6):e200397. doi: 10.1001/jamasurg.2020.0397. Epub 2020 Jun 17.
    pmid
    32236507
    type
    DERIVED
  2. citation
    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, Marreaud S, van der Graaf WT, Zalcberg JR, Litiere 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.
    pmid
    26573069
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        ade 3 or 4 events occurred in 30.9% of patients in the imatinib arm and 18.3% of patients in the placebo arm. </li></ul></div></li><li><a href="/clinicaltrials/NCT00103168">EORTC-62024</a> (NCT00103168) was a phase III open-label trial of 908 patients with fully resected (R0 or R1 margin) <em class="gene-name">KIT</em>-variant GI
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        30.9% of patients in the imatinib arm and 18.3% of patients in the placebo arm. </li></ul></div></li><li><a href="/clinicaltrials/NCT00103168">EORTC-62024</a> (NCT00103168) was a phase III open-label trial of 908 patients with fully resected (R0 or R1 margin) <em class="gene-name">KIT</em>-variant GISTs at intermediate or high ri
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      source title
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      source update dates
      1. context
        Updated: December 13, 2024
        datetime
        2024-12-13T12:00:00Z
        display
        December 13, 2024

    Preserved source evidence · Not medical advice