Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index
- Conditions
- gastrointestinal stromal tumorTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2024-515432-71-00
- Lead Sponsor
- Centre Hospitalier Regional De Marseille
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Man or woman 18 years old or over and Performance Status: 0-2, No prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy for the past 3 years, Subject with a gastrointestinal stromal tumor, intermediary risk from the Armed Forces Institute of Pathology classification [Miettenen 2006], Subject with Genomic Grade Index higher than 10 determined by CGH array, Subject with surgery for primary tumor performed from 2 weeks to 3 months before starting adjuvant Imatinib mesylate, Subject with no evidence of residual macroscopic disease after surgery (RO). Microscopically infiltrated margins, or supposed to be are allowed (R1), Subjects with absence of distant metastases
Subjects meeting any of the following criteria must not be enrolled, Minors or pregnant or breast-feeding women., Subject with a contraindication to Imatinib, a known hypersensitivity to the active substance or to any of the excipients (ambivalence clause), Subject treated with medicinal products that induce CYP3A4, Subject who have experienced spontaneous tumor rupture before surgery (risk of spread), Subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from tumor block, Subject whose mutational status meets the wild phenotype definition as evidenced by sequencing from tumor block
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method