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Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index. Multicenter, prospective, randomized study.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515432-71-00
Enrollment
80
Registered
2024-07-26
Start date
2016-09-13
Completion date
Unknown
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastrointestinal stromal tumor

Brief summary

The efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan

Detailed description

1-year, 2-year and 3-year metastasis-free survival based on a thoraco-abdominal and pelvic CT-scan. Metastasis-free survival will be defined as the time from the baseline visit (feedback of the randomization to the patient) and the earliest date of documented radiological occurrence of metastasis., Overall survival, Clinical and biological tolerance, Patients’ quality of life assesssed by a generic questionnaire: the French version of the SF36 [Leplège 1998] and s specific questionnaire, the French version of the EORTC QLQ-C30. EORTC QLQ-C30

Interventions

DRUGIMATINIB

Sponsors

Centre Hospitalier Regional De Marseille
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan

Secondary

MeasureTime frame
1-year, 2-year and 3-year metastasis-free survival based on a thoraco-abdominal and pelvic CT-scan. Metastasis-free survival will be defined as the time from the baseline visit (feedback of the randomization to the patient) and the earliest date of documented radiological occurrence of metastasis., Overall survival, Clinical and biological tolerance, Patients’ quality of life assesssed by a generic questionnaire: the French version of the SF36 [Leplège 1998] and s specific questionnaire, the French version of the EORTC QLQ-C30. EORTC QLQ-C30

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026