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临床试验/JPRN-jRCTs011180028
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

发起方
Taketomi Akinobu

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eoadjuvant FOLFOX in rectal cancer | 临床试验