JPRN-jRCTs031180278进行中（未招募）2 期
A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer - NAIR study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Ito Masaaki
- 入组人数
- 128
研究概览
简要总结
暂无简介。
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) Rectal cancer located within 5cm from the anal verge of 3cm from the dentate line
- •2) Histologically proven adenocarcinoma
- •3) Clinical T3 N-any M0
- •4) Without invasion to the external anal sphincter
- •5) Radical surgery is expected
- •6) Age: 20 yr.<= <=75 yr.
- •7) Having enough organ function as follows
- •1. WBC > 3,000/mm3
- •2. Plt > 100,000/mm3
- •3. Hb > 8.0g/dl
- •4. GOT < 100IU/L
- •5. GPT < 100IU/L
- •6. T-Bil. < 2.0mg/dl
- •7. Cr < 1.5mg/dl
- •8. PT > 50%
- •8) Performance Status (ECOG):0 or 1
- •9) No history of chemotherapy or radiotherapy
- •10) The consent in writing has obtained
排除标准
- •1) Hoping APR
- •2) Undergoing ISR is difficult
- •3) Having severe anal dysfunction before surgery
- •4) Double cancers
- •5) Having severe complications as follows:
- •1.Poor controlled Diabetes Mellitus
- •2.Poor controlled hypertension
- •3.Interstitial pneumonia, Pulmonary fibrosis, Severe emphysema
- •6) Chronic active type B or type C hepatitis
- •7) Blood transfusion within 2 weeks
- •8) Pregnant or Lactating
- •9) Inadequate due to mental illness or mental symptoms
- •10) The consent has not obtained
- •11) Judged by doctors as inadequate
研究者
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