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

Phase 1

Recruiting

• Conditions: pancreatic cancer, biliary tract cancer, kideny cancer, etc.; gastrointestinal proximal malignant tumors; D010190, D001661, D0002367, etc.

• Registration Number: JPRN-jRCTs052220157
• Lead Sponsor: Sasaki Ryohei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-24
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified