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Sponsors and Collaborators: |
Centre Leon Berard Institut Gustave Roussy |
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Information provided by: | Centre Leon Berard |
ClinicalTrials.gov Identifier: | NCT00367861 |
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 feasability of Glivec® treatment interuption with reintroduction at progression in GIST patients.
Condition | Intervention | Phase |
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Sarcoma Gastro-Intestinal Stromal Tumors (GIST) |
Drug: interruption of Glivec® |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 564 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | May 2018 |
Arms | Assigned Interventions |
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interruption of Glivec®: Experimental |
Drug: interruption of Glivec®
interruption of Glivec®
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean Yves Blay, M.D, Ph.D | +33607507064 | blay@lyon.fnclcc;fr |
Contact: Axel Le Cesne, M.D | +33142114211 | lecesne@igr.fr |
France | |
Centre Leon Berard | Recruiting |
Lyon, France, 69008 | |
Principal Investigator: Isabelle Ray-Coquard, M.D., Ph.D | |
Sub-Investigator: David Perol, M.D. | |
Sub-Investigator: Jean-Yves Blay, M.D. Ph.D | |
Sub-Investigator: Jérôme Fayette, MD | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94850 | |
Principal Investigator: Axel Le Cesne, MD | |
Hopital Edouard Herriot | Recruiting |
Lyon, France, 69008 | |
Principal Investigator: Jean-Yves Blay, M.D. Ph.D | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59000 | |
Sub-Investigator: Antoine Adenis, MD | |
Institut Bergonié | Recruiting |
Bordeaux, France, 33000 | |
Sub-Investigator: Binh Bui Nguyen, MD | |
Institut Paoli Calmette | Recruiting |
Marseilles, France, 13000 | |
Sub-Investigator: Patrice Viens, M.D. Ph.D | |
Centre Alexis Vautrin | Recruiting |
Nancy, France, 57000 | |
Sub-Investigator: Maria Rios, M.D. | |
Hopitaux de La Timone | Recruiting |
Marseille, France, 13000 | |
Sub-Investigator: Florence Duffaud, MD Ph D |
Principal Investigator: | Jean Yves Blay, M.D., Ph.D | Centre Leon Berard, INSERM U590 & Hopital Edouard Herriot |
Principal Investigator: | Axel Le Cesne, M.D. | Institut Gustave Roussy |
Study ID Numbers: | CST1571BFR14, ET2002-021 |
Study First Received: | August 21, 2006 |
Last Updated: | November 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00367861 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
GIST Glivec® randomized phase III |
Imatinib Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Malignant mesenchymal tumor |
Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Soft tissue sarcomas |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |