Clinical study of safety and efficacy of peritoneal catheter placement and saline injection as artificial ascites for space-making radiotherapy in patient with abdominal or pelvic malignant tumor

Onoe Tsuyoshi0 sites18 target enrollmentFebruary 2, 2022

Overview

No summary available.

Registry

who.int

Start Date

February 2, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Onoe Tsuyoshi

•(1\) Histologically or clinically confirmed primary or metastatic malignant tumors (carcinoma or sarcoma) located in the abdomen and pelvis.
•(2\) The presence of a bowel within a 10 mm distance from GTV
•(3\) ability to maintain a prone or supeine position during radiotherapy
•(4\) Age of 18 years or older
•(5\) Eastern Cooperative Oncology Group performance status 0, 1, and 2
•(6\) prognosis of \> 6 months, based on New Katagiri score
•(7\) provision of written informed consent

•(1\) Patients who potentially have severe tissue adhesion in the area where catheter will be placed
•(2\) Patients with disseminated metastasis of the peritoneum detected by cytology or radiography in the area of catheter insertion and/or placemen
•(3\) patients with radiation\-sensitive tumors, including malignant lymphoma, myeloma, or germ cell tumor
•(4\) Platelet count\<50,000 / mm3
•1\. Heart disease, hypertension, diabetes, psychiatric disease, seizure and seizure disease, intractable infectious disease whose medical treatment is difficult to control.
•2\. Patients who take antiplatelet drugs ,anticoagulants, and is difficult to discontinue them
•(6\)Woman who is pregnant , lactating or wishing to have children
•(7\)Patient who is deemed inappropriate by the doctor due to medical or psychological factors