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

NCT00367861 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2014-02-24

No results posted yet for this study

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.

Conditions

  • Sarcoma
  • Gastro-intestinal Stromal Tumors (GIST)

Interventions

DRUG

interruption of Glivec®

interruption of Glivec®

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Jean Yves Blay, M.D., Ph.D · Centre Leon Berard, INSERM U590 & Hopital Edouard Herriot

  • Axel Le Cesne, M.D. · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2012-04-30
Completion
2013-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00367861 on ClinicalTrials.gov