This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
Centre Leon Berard Identifier:
First received: August 21, 2006
Last updated: February 21, 2014
Last verified: February 2014
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 Intervention Phase
Sarcoma Gastro-intestinal Stromal Tumors (GIST) Drug: interruption of Glivec® Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Centre Leon Berard:

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

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

Enrollment: 564
Study Start Date: May 2002
Study Completion Date: May 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: interruption of Glivec® Drug: interruption of Glivec®
interruption of Glivec®

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00367861

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
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
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Centre Leon Berard Identifier: NCT00367861     History of Changes
Other Study ID Numbers: CST1571BFR14
Study First Received: August 21, 2006
Last Updated: February 21, 2014

Keywords provided by Centre Leon Berard:
phase III

Additional relevant MeSH terms:
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 processed this record on September 21, 2017