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

JRCT ID: jRCTs042210139

Registered date:02/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: abdominal or pelvic malignant tumors
• Date of first enrollment: 12/10/2022
• Target sample size: 18
• Study type: Interventional
• 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 Outcome

Phase 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 maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Onoe Tsuyoshi