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

Assistance Publique Hôpitaux de MARSEILLE0 个研究点目标入组 80 人开始时间: 2015年6月19日最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•- Subject with no prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy
•- Subject with a Performance Status between 0-2
•- 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 2 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Subject under 18 years old 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;

发起方