A Stratified Phase II Study of Neoadjuvant Chemotherapy Given Before SCPRT as Treatment for Patients With MRI-Staged Operable Rectal Cancer at High Risk of Metastatic Relapse
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Proportion of patients who commence neoadjuvant chemotherapy and radiotherapy and then undergo surgical resection
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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying giving oxaliplatin, leucovorin, and fluorouracil together, before and after radiation therapy and surgery in treating patients with rectal cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To assess the feasibility of introducing 8 weeks of neoadjuvant oxaliplatin and fluorouracil followed by radiotherapy and immediate surgical resection in patients with resectable adenocarcinoma of the rectum.
Secondary
- Determine feasibility of achieving dose intensity for chemotherapy and radiotherapy in these patients.
- Determine the safety, in terms of NCI CTCAE version 4 toxicities, including postoperative complication rate (up to 30 days postoperatively), and late toxicity assessment at 1 year following surgery, in these patients.
- Determine how active is the neoadjuvant chemotherapy, in terms of down staging the rectal cancer, local recurrence-free, distant metastasis-free, and overall survival at 1 year following 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
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
干预措施: Leucovorin (Drug)
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
干预措施: fluorouracil (Drug)
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
干预措施: leucovorin calcium (Drug)
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
干预措施: oxaliplatin (Drug)
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
干预措施: adjuvant therapy (Procedure)
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
干预措施: neoadjuvant therapy (Procedure)
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
干预措施: therapeutic conventional surgery (Procedure)
Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Proportion of patients who commence neoadjuvant chemotherapy and radiotherapy and then undergo surgical resection
时间窗: Two years
次要结局
- Safety in terms of NCI CTCAE v 4 toxicities up to 30 days postoperatively and late toxicity at 1 year after surgery(Two years)
- Complete response(Two years)
- Efficacy in terms of down-staging rectal cancer(Two years)
- Feasibility in terms of achieved dose intensity for chemotherapy and radiotherapy(Two years)
- Local recurrence-free, distant metastasis-free, and overall survival at 1 year after surgery(Two years)