JPRN-jRCTs011180028已完成2 期
The pilot study on surgical safety after neoadjuvant chemotherapy of mFOLFOX6 for locally advanced rectal cancer. - R-NAC01
Taketomi Akinobu0 个研究点目标入组 44 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
The operations after the 4 courses of preoperative mFOLFOX6 was safe and promising strategy to improve the prognosis in locally advanced rectal cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old(—)
- 性别
- All
入选标准
- •1. The cases histologically diagnosed as rectal cancer by endoscopic biopsy.
- •2. clinical stage-II or III by preoperative imaging.
- •3. The main occupation of the primary tumor site is located upper of lower rectum.
- •4. The age is 20 years old and older and under 75 years old.
- •5. Performance Status(ECOG) is 0 or 1.
- •6. No history of surgical treatment for primary tumor.
- •7. Cases without a history of chemotherapy, radiation, and so on.
- •8. Cases of major organ function is maintained.
排除标准
- •1. Double cancer
- •2. Pregnant or lactating women.
- •3. Patients with a history of colorectal cancer(Excluding mucosal cancer).
- •4. Patients with peripheral sensory neuropathy(CTCAE v4.0> Grade 1).
- •5. Patients with infectious disease requiring systemic therapy.
- •6. Patients with uncontrolable cardiovascular disease.
- •7. Patients with a history of mental disorder.
研究者
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