Ancillary Study of miR-31-3p and miR-31-5p Expression Levels in Patients Enrolled in the PETACC-8 Study, and of the Predictive Role of miR-31-3p Expression Level on Clinical Outcomes of Patients Treated With Cetuximab
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,808
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
This is a prospective-retrospective study to determine if the expression of the miRNA's miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from anti-EGFR therapy in stage III Colon Cancer. The present study will utilize FFPE tumor samples collected from patients enrolled in the PETACC-8 study conducted by the Fédération Francophone de Cancérologie Digestive (FFCD). This phase 3 clinical trial prospectively randomized fully resected stage III colon cancer patients to receive adjuvant treatment with either FOLFOX-4 plus cetuximab or FLOFOX-4 alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient included in PETACC08 study
- •Signed informed consent for translational study
- •FFPE tumor sample available for miR-31-3p and miR-31-5p expression testing
排除标准
- •Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
研究组 & 干预措施
FOLFOX-4 plus Cetuximab
干预措施: Cetuximab (Drug)
FOLFOX-4 plus Cetuximab
干预措施: FOLFOX (Drug)
FOLFOX-4
干预措施: FOLFOX (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years
Difference in Disease Free Survival (DFS) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only .
Prognostic and predictive value of miR-31-3p expression on Disease Free Survival (DFS)
时间窗: From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved DFS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to DFS in patients with RAS/BRAF WT tumors .
次要结局
- Prognostic and predictive value of miR-31-3p expression on SAR(From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years)
- Overall Survival (OS)(From date of randomization until date of death from any cause, assessed up to 7 years)
- Prognostic and predictive value of miR-31-3p expression on OS(From date of randomization until date of death from any cause, assessed up to 7 years)
- Survival after recurrence (SAR)(From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years)