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| ID | Type | Description | Link |
|---|---|---|---|
| ERID-KSOPKR-0091/2019 | Other Identifier | Ethics Committee, Institute of Oncology Ljubljana |
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This prospective observational study evaluates the safety and effectiveness of stereotactic body radiotherapy (SBRT) for liver tumors, liver metastases, and pancreatic tumors. The study focuses on systematic monitoring and optimization of the SBRT treatment process, including adherence to the implemented protocol, with the aim of simplifying methods while maintaining treatment safety.
Stereotactic body radiotherapy (SBRT) is an advanced radiotherapy technique that enables delivery of high radiation doses to tumors with high precision while limiting exposure of surrounding healthy tissues. This study prospectively follows patients treated with SBRT for primary liver tumors, liver metastases, and pancreatic tumors at the Institute of Oncology Ljubljana.
The primary aim is to monitor and optimize all steps of the SBRT workflow, including protocol adherence, in order to ensure safe implementation and to evaluate treatment outcomes. The study also aims to assess whether the established SBRT protocol can be simplified without compromising patient safety.
Treatment safety and effectiveness outcomes will be evaluated during follow-up, and the collected data will be used to support further refinement of SBRT procedures for upper gastrointestinal tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT Treatment | Experimental | Patients with liver tumors, liver metastases, or pancreatic tumors treated with stereotactic body radiotherapy (SBRT) according to the institutional protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Radiation | Stereotactic body radiotherapy (SBRT) delivered according to the institutional protocol for treatment of liver tumors, liver metastases, and pancreatic tumors, with high-dose hypofractionated radiation and image-guided radiotherapy techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Safety (Radiotherapy-Related Toxicity) | Assessment of acute and late treatment-related toxicity after stereotactic body radiotherapy (SBRT) for liver tumors, liver metastases, and pancreatic tumors, evaluated according to standard toxicity criteria. | From start of SBRT up to 12 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| D008107 |
| Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |