A Phase III Study Evaluating the Role of Perioperative Chemotherapy in Patients With Potentially Resectable Hepatic Colorectal Metastases
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 563
- 主要终点
- Recurrence-free Survival (RFS)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to kill tumor cells or stop them from growing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether giving combination chemotherapy before and after surgery is more effective than giving combination chemotherapy after surgery.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before and after surgery to see how well it works compared to giving combination chemotherapy after surgery in treating patients with colorectal cancer with liver metastases that could be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To evaluate the difference in recurrence-free survival (RFS) of patients with potentially resectable hepatic colorectal metastases receiving perioperative (preoperative plus postoperative) adjuvant chemotherapy vs only postoperative adjuvant chemotherapy following liver resection for colorectal metastases.
Secondary
- To compare the proportion of patients between study arms who are R0 or R1 resected, alive, and free of recurrence at 6 months.
- To compare RFS between study arms in the cohort of patients event-free at 6 months.
- To compare overall survival between study arms.
- To evaluate the difference in R0 and combined R0 + R1 resection rates in patients receiving neoadjuvant therapy and those undergoing initial surgical resection.
- To compare the postoperative morbidity profile between study arms.
- To evaluate the safety and toxicity profile of postoperative and perioperative administration of chemotherapy and bevacizumab.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Recurrence-free Survival (RFS)
时间窗: From study entry until the date of recurrence or death or for a maximum of 5 years.
Time to recurrence or death
次要结局
- RFS of Patients Event-free(From study entry until the date of recurrence or for a maximum of 6 months.)
- Overall Survival(From study entry until the time of death or for a maximum of 5 years.)
- The Difference in R0 and Combined R0 + R1 Resection Rates Between the Two Arms.(Assessed at the time of surgery)
- Frequencies of Selected Postoperative Surgical Complications and Other Adverse Events Within 30 Days of Surgery(Assessed within 30 days from the time of surgery)
- Frequencies of Adverse Events as Assessed by the NCI CTCAE v4.0(From study entry through 3 months after the last treatment dose.)