2024-515432-71-00招募中3 期
Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index. Multicenter, prospective, randomized study.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 14
- 主要终点
- The efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan
研究概览
简要总结
Assess the efficacy of adjuvant Imatinib on rate of metastatic relapse at 2 years in patients with intermediate-risk gastrointestinal stromal tumor presenting a high Genomic Grade Index.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan
The efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan
次要结局
- 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
研究者
Coordonator investigator
Scientific
Centre Hospitalier Regional De Marseille
研究点 (14)
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