A Randomized Phase III Study Investigating the Role of Oxaliplatin Duration (3 Months Versus 6 Months) in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 1,580
- 试验地点
- 17
- 主要终点
- disease-free survival
研究概览
简要总结
This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
详细描述
This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer. In addition, we would like to characterize pharmacogenomic profile associated with toxicities and gene expression profiling to predict the recurrence of colon cancer as parallel study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Curatively resected, histologically confirmed colon adenocarcinoma
- •AJCC/UICC high-risk stage II, stage III colon cancer
- •Age over 18 years old
- •Performance status (ECOG scale): 0-1
- •Adequate major organ functions
- •Patients should sign a written informed consent before study entry
排除标准
- •Colon cancer other than adenocarcinoma
- •Rectal cancer
- •R1 or R2 resections
- •Other malignancies within the last 5 years
- •Symptomatic peripheral sensory neuropathy
- •Presence of other serious disease
- •Lactating or pregnant women
- •Fertile women
研究组 & 干预措施
FOLFOX_12 or CAPOX_8
6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
干预措施: oxaliplatin (Drug)
FOLFOX_6 or CAPOX_4
3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
干预措施: oxaliplatin (Drug)
结局指标
主要结局
disease-free survival
时间窗: 3 years
次要结局
- safety profiles(3 years)
- overall survival(3 years)
- quality of life(3 years)
研究者
Young Suk Park
Professor
Samsung Medical Center