Safety and Efficacy of High Precision Radiotherapy Combined with a Nonwoven Fabric Bioabsorbable Spacer for Tumors Located Colse to Gastrointestinal Tract : Space Making Radiotherapy - SMRT

Sasaki Ryohei0 个研究点目标入组 6 人开始时间: 2023年1月24日最近更新: 2023年11月20日

适应症

试验速览

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•1) Those who have abdominal or pelvic tumors pathologically diagnosed as malignant.
•2) Those who are indicated for high-dose radiotherapy such as Intensity Modulated Radiation Therapy (IMRT) or Stereotactic Body Radiation Therapy (SBRT).
•3) Those who have located tumor within a certain radiation field.
•4) Those who have narrow gap between malignant tumor and surrounding organs (10mm or less).
•5) Those who are judged to be able to place a spacer and receive radiotherapy according to the protocol.
•6) Those who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 at the time of informed consent.
•7) The function of major organs is preserved.
•8) Those who are 20 years of age or older at the time of obtaining consent.
•9) Those who can fill out the consent form about participation in this clinical research by themselves.

•1) Expected prognosis is less than 6 months.
•2) Those who have a history of radiation therapy at the treatment area in this study..
•3) Those who have an active gastrointestinal ulcer.
•4) Those who have an ascites or pleural effusion suspected to be malignant.
•5) Those who have a metal stent placed near the irradiation field.
•6) Those who cannot use iodine contrast media or gadolinium contrast media.
•7) Those who are allergic to polyglycolic acid.
•8) Those who have an active infection at the treatment area.
•9) Those who are judged to be inappropriate by the person in charge of this research.

发起方

Sasaki Ryohei