Safety and Efficacy of Radiotherapy Combined with a Nonwoven Fabric Bioabsorbable Spacer

JRCT ID: jRCTs052220157

Registered date:24/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer, biliary tract cancer, kideny cancer, etc.
• Date of first enrollment: 06/09/2023
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Placement of an absorbable spacer between the gastrointestinal tract and the tumor to secure a safer distance for curative radiotherapy for gastrointestinal proximal malignant tumors

Outcome(s)

• Primary Outcome: PTV V95(%) before and after absorbable spacer placement

Secondary Outcome

Efficacy endpoint
1) Dose distribution
2) Completion of radiotherapy

Safety endpoint
1) Occurrence of diseases
2) Defects and their details in absorbable spacer

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Sasaki Ryohei
• Source(s) of Monetary Support: Alfresa Pharma Corporation