Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Median Progression-free Survival (PFS) Time
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of systemic chemotherapy and cetuximab, in terms of progression-free survival at 3 years, in patients with completely resected peritoneal carcinomatosis of colorectal origin.
Secondary
- Determine the therapeutic strategy among patients who are or are not fit to receive chemotherapy.
- Determine progression-free survival at 5 years and overall survival at 3 and 5 years in these patients.
- Determine the overall tolerability (mortality, morbidity) of this regimen, including surgery, in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
研究组 & 干预措施
Chemotherapy + Cetuximab
Surgery + Chemotherapy + Cetuximab
干预措施: fluorouracil (Drug)
Chemotherapy + Cetuximab
Surgery + Chemotherapy + Cetuximab
干预措施: cetuximab (Biological)
Chemotherapy + Cetuximab
Surgery + Chemotherapy + Cetuximab
干预措施: leucovorin calcium (Drug)
Chemotherapy + Cetuximab
Surgery + Chemotherapy + Cetuximab
干预措施: oxaliplatin (Drug)
Chemotherapy + Cetuximab
Surgery + Chemotherapy + Cetuximab
干预措施: adjuvant therapy (Procedure)
Chemotherapy + Cetuximab
Surgery + Chemotherapy + Cetuximab
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Median Progression-free Survival (PFS) Time
时间窗: Since surgery, up to 5 years
Progression-free survival time is defined as the time from the date of surgery to the date of progression (as per RECIST v1.1) or death of any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- 30-day Mortality Rate(from the date of surgery up to 30 days)
- Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery(from the date of surgery up to 30 days)
- Overall Survival (OS) Time(from surgery, up to five years.)