NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042210139

Registered date:02/02/2022

Petitoneal catheter placement and space-making radiotherapy with artificial ascites for abdominal or pelvic malignant tumors

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedabdominal or pelvic malignant tumors
Date of first enrollment12/10/2022
Target sample size18
Countries of recruitment
Study typeInterventional
Intervention(s)External beam irradiation, percutaneus cacheter insersion, catheter placement into peritoneum cavity or extraperitoneal space , Saline injection at simulation and each treatment session

Outcome(s)

Primary OutcomePhase I part: Morbidity (Rate of toxicity greater than grade IIIb which is obviously attributed to percutaneous catheter insertion and placement) Phase II part: Succeful rate (Rate of the distance between bowel and GTV of at least 10-mm distance at Simulation)
Secondary Outcome(1)The shortest distance between bowel and GTV at each radiation therapy session (2)Dosimetric outcomes (PTV,Bowel) (3)all adverse events during radiation therapy (4)Severe adverse events until the 10th week after the end of radiation therapy

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria(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
Exclude criteria(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 (5 ) 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

Related Information

Contact

Public contact
Name Tsuyoshi Onoe
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail t.onoe@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Tsuyoshi Onoe
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail t.onoe@scchr.jp
Affiliation Shizuoka Cancer Center