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临床试验/ACTRN12614001219673
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Multiparametric MRI as a Predictor of Tumour Response in Patients with Anal Canal Cancer Managed with Chemoradiotherapy

Dr Michael Jones0 个研究点目标入组 20 人开始时间: 2014年11月19日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1.Patient capable of providing informed consent
  • 2.Patient deemed suitable for protocol treatment as
  • assessed by Radiation and Medical Oncologists
  • 3.Histological diagnosis of invasive primary squamous
  • cell carcinoma of the anal canal
  • 4.TNM Stage: T2-4, N0-3 based on the
  • following diagnostic workup
  • a.History & physical examination
  • b.Digital Rectal Exam (DRE) stating primary size and
  • distance from anal verge
  • c.Groin examination with documentation of any
  • lymphadenopathy (location: right vs. left; medial vs.
  • lateral; mobile vs. fixed; and size)
  • d.Clinically positive nodes
  • i .Small inguinal nodes < 1cm in size felt to be clinically
  • positive must be confirmed via biopsy
  • ii. A biopsy is not needed for enlarged inguinal,
  • perirectal or pelvic nodes on examination or imaging
  • if >1cm and considered to be clinically positive
  • e.Anal biopsy
  • f.CT abdomen and pelvis

排除标准

  • 1.ECOG performance status >2
  • 2.Significant comorbidities that would interfere with
  • the completion of treatment
  • 3.Renal insufficiency (Creatinine > 150)
  • 4.Prior radiotherapy to the pelvis that would overlap in
  • the treatment fields
  • 5.Prior surgery for cancer of the anus that removed all
  • macroscopic cancer
  • 6.Prior systemic chemotherapy for anal cancer
  • 7.Evidence of distant metastases (M1) if this precludes
  • radical pelvic treatment
  • 8.Women who are pregnant or lactating
  • 9.Inability to have a MRI due to:
  • a.Implanted magnetic metal e.g. intraocular metal
  • b.Pacemaker / Implantable defibrillator
  • c.Extreme claustrophobia

研究者

发起方
Dr Michael Jones

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