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Gastrointestinal Stromal TumorPhase 3NCT00103168

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

A Phase 3 study testing imatinib mesylate in people with Gastrointestinal Stromal Tumor, run by European Organisation for Research and Treatment of Cancer - EORTC at 50 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Gastrointestinal Stromal Tumor
What is being tested?
imatinib mesylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
908 participants
Where
50 sitesin 6 countries
Study dates
Dec 2004to Sep 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

50 sites in 6 countries.

50 sites in 6 countries

France43 sites

  • Centre Hospitalier d'Abbeville

    Abbeville, 80101

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Avicenne

    Bobigny, 93009

  • Institut Bergonie

    Bordeaux, 33076

  • Hopital Ambroise Pare

    Boulogne-Billancourt, 92100

  • C.H.U. de Brest

    Brest, 29200

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospitalier de Dreux

    Dreux, 28100

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • C. H. Du Mans

    Le Mans, 72037

  • Hopital Robert Boulin

    Libourne, 33500

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • CHU de la Timone

    Marseille, 13385

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • CHR Hotel Dieu

    Nantes, 44093

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45100

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Cochin

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • Centre Hospitalier - Pau

    Pau, 64046

  • CHU - Robert Debre

    Reims, 51092

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033

  • Centre Eugene Marquis

    Rennes, 35064

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Spain2 sites

  • Complejo Hospitalario de Leon

    León, 24008

  • Grupo Espanol de Investigacion del Cancer de Mama

    Madrid, 28700

Other trials in Spain

United Kingdom2 sites

  • Gartnavel General Hospital

    Glasgow, Scotland, G12 0YN

  • Christie Hospital

    Manchester, England, M20 4BX

Other trials in United Kingdom

Australia1 site

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

Other trials in Australia

Denmark1 site

  • Herlev University Hospital

    Herlev, DK-2730

Other trials in Denmark

Germany1 site

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
imatinib mesylate
Keywords
gastrointestinal stromal tumor
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    400 mg/day for 2 years

Study groups in NCT00103168
Study groupRoleWhat they receive
Imatinib mesylateExperimental400 mg/day for 2 years
Receives: Drug: imatinib mesylate
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (3)

  1. Relapse-free survival

  2. Relapse-free interval

  3. Adverse events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionOct 2008
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
908 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103168
Sponsor's protocol ID
EORTC-62024
Other IDs
EORTC-62024, ISG-62024, FRE-FNCLCC-EORTC-62024, GEIS-EORTC-62024, 2004-001810-16, 2004
Status last verified
Jul 2018
First submitted
7 Feb 2005
Last updated
9 Jul 2018
Results posted
No

Publications

  • 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.

    PubMed 32236507

  • 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.

    PubMed 26573069

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing imatinib mesylate in people with Gastrointestinal Stromal Tumor, run by European Organisation for Research and Treatment of Cancer - EORTC at 50 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in France, Spain, United Kingdom, Australia, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00103168, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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