跳至主要内容
临床试验/JPRN-jRCT1030220350
JPRN-jRCT1030220350招募中3 期

JCOG1915: Less intensive post-operative surveillance in low risk colorectal cancer patients - LESS study

Kanemitsu Yukihide0 个研究点目标入组 680 人开始时间: 2022年9月27日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
680

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) Pathologically proven colorectal adenocarcinoma.
  • 2) Tumor is mainly located between cecum and lower rectum.
  • 3) Tumor resection with D2 or D3 lymph node dissection with open or laparoscopic approach was performed, regardless of with or without lateral lymph node dissection (Robotic surgery is allowed for enrollment).
  • 4) R0 resection was performed.
  • 5) No distant metastasis defined as
  • 1. Chest ; Chest CT or FDG-PET/CT
  • 2. Abdomen ; Abdomen CT or FDG-PET/CT
  • 6) 56 days after surgery.
  • 7) pStage I cancer, or pStage II cancer without any following factors (JSCCR classification 9th ed.);
  • (a) Depth of tumor: pT4,
  • (b) Tumor budding: BD3,
  • (c) Perineural invasion: Pn1,
  • (d) Desmoplastic reaction (DR) category: intermediate/immature
  • 8) Age at registration is of 20 to 75 years old.
  • 9) ECOG Performance status is 0 or 1.
  • 10) No prior chemotherapy or radiotherapy to the abdomen or pelvis.
  • 11) Witten informed consent is obtained

排除标准

  • 1) Synchronous or metachronous (within 5 years) malignancies
  • 2) Infections which needs systemic treatment.
  • 3) Severe psychological disease.
  • 4) Continuous systemic corticosteroid or immunosuppressant treatment.
  • 5) Routine thoracoabdominal and pelvic CT scan at least once a year due to past medical history / comorbidities.

研究者

发起方
Kanemitsu Yukihide

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