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Prospective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance

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: NCT00367861
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : February 24, 2014
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
Centre Leon Berard

Brief Summary:
Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.

Condition or disease Intervention/treatment Phase
Sarcoma Gastro-intestinal Stromal Tumors (GIST) Drug: interruption of Glivec® Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicentric Randomized Study of Glivec® in Patients With Advanced Gastrointestinal Stromal Tumors Expressing C-kit Comparing Treatment Interruption After 5 Years vs Treatment Maintenance
Study Start Date : May 2002
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: interruption of Glivec® Drug: interruption of Glivec®
interruption of Glivec®

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]
    to compare progression free survival beyond 2 years in patients treated by Glivec® achieving a CR, PR or SD at 5 years. Patients will be randomized either interruption of Glivec® until progression w/RECIST criteria and the re-start (group 1) or(/vs) maintenance of Glivec® (group 2).

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    To compare overall survival beyond 2 years in the two groups of randomized patients.

  2. Toxicity [ Time Frame: 7 years ]
    Evaluation of toxicity during inclusion in the study

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients 18 years of age or over.
  2. Histologically documented diagnosis of malignant GIST.
  3. Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay.
  4. Performance status 0,1, 2, 3 (ECOG)
  5. Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.0 x 109/L, platelets > 100 x 109/L.
  6. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 2 weeks (according to updated Invest. Brochure) following discontinuation of study drug.
  7. Written, voluntary, informed consent.

Exclusion Criteria:

  1. Patient has another malignant tumor in CR<3 years (except if the other primary malignancy is inactive and not requiring active intervention). Previous basal cell skin cancer or a cervical carcinoma in situ are allowed.
  2. Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
  3. Female patients who are pregnant or breast-feeding.
  4. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
  5. Patients received chemotherapy within 2 weeks prior to study entry, unless the disease is rapidly progressing
  6. Patients had a major surgery within 2 weeks prior to entry study
  7. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  8. Previous treatment with Glivec®

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): NCT00367861

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Institut Bergonié
Bordeaux, France, 33000
Centre Oscar Lambret
Lille, France, 59000
Centre Leon Berard
Lyon, France, 69008
Hopital Edouard Herriot
Lyon, France, 69008
Institut Paoli Calmette
Marseilles, France, 13000
Hopitaux de La Timone
Marseille, France, 13000
Centre Alexis Vautrin
Nancy, France, 57000
Institut Gustave Roussy
Villejuif, France, 94850
Sponsors and Collaborators
Centre Leon Berard
Gustave Roussy, Cancer Campus, Grand Paris
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Principal Investigator: Jean Yves Blay, M.D., Ph.D Centre Leon Berard, INSERM U590 & Hopital Edouard Herriot
Principal Investigator: Axel Le Cesne, M.D. Gustave Roussy, Cancer Campus, Grand Paris


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centre Leon Berard Identifier: NCT00367861     History of Changes
Other Study ID Numbers: CST1571BFR14
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014

Keywords provided by Centre Leon Berard:
phase III

Additional relevant MeSH terms:
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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