Enlargement of the distance between tumor and adjacent normal tissue/organs (Organs at risk=OAR) by interventional insertion of balloon catheters RAD317
- Conditions
- C22.1Secondary malignant neoplasm of large intestine and rectumC78.5C22.0Liver cell carcinomaIntrahepatic bile duct carcinoma
- Registration Number
- DRKS00011126
- Lead Sponsor
- niversitätsklinikum Magdeburg
- Brief Summary
Results: In 31 cases, at least one balloon catheter was administered. The mean D1cc of the OAR in the group with balloon(s) was 12.6 Gy compared with 16 Gy in the virtual cohort without the device, therefore significantly lower (p < 0.001). Overall, there were no acute complications. Severe (> 2 CTCAEv4.03) late complications observed in 3/31 (9.6%) patients during follow-up period after brachytherapy were most certainly not due to the balloon application. Side effects were probably associated with pre-existing serious diseases and potentially additional local late effects of the irradiation in general rather than with the balloon catheters. Conclusions: The distancing of the adjacent OARs allows a higher D100 value of CTV, therefore allowing for more efficient local control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 31
Indication for high-dose-rate-brachytherapy (HDR-BT) of subcapsular liver malignomas
- Declaration of consent for brachytherapy and for scientific purposes
- Age > 18 years, no upper age limit
- no contraindications to HDR-BT of the liver
Contraindikations to HDR-BT of liver
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of the dosimetric effect of distancing subcapsular liver tumors from adjacent normal tissue/organs (organs at risk = OAR) by inserting interventional balloon catheters.
- Secondary Outcome Measures
Name Time Method Safety