Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases (MAESTRO)
Hepatic Metastasis
About this trial
This is an interventional treatment trial for Hepatic Metastasis focused on measuring Magentic Resonance-guided Adaptive Stereotactic Body Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- confirmed underlying solid malignant tumor (no germ cell tumor, leukemia, lymphoma)
- 1-3 hepatic metastases confirmed by pre-therapeutic MRI
- indication for SBRT of 1-3 hepatic metastases
- maximum diameter each hepatic metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12 cm)
- age ≥ 18 years of age
- Karnofsky Performance Score ≥ 60%
- ability to lie still on the radiotherapy treatment couch for at least one hour
- ability to hold one's breath for more than 25 seconds
- for women with childbearing potential, adequate contraception
- ability of subject to understand character and individual consequences of the clinical trial
- written informed consent (must be available before enrolment in the trial)
Exclusion Criteria:
- refusal of the patients to take part in the study
- patients with primary liver cancer (eg. HCC, CCC)
- patients after liver transplantation
- impairment of liver function to an extent contraindicating radiotherapy (to the discretion of the treating radiation oncologist)
- active acute hepatic/biliary infection (e.g. hepatitis, cholangitis, cholecystitis)
- previous radiotherapy of the hepatobiliary system, if previous and current target volumes overlap MAESTRO Study Studienprotokoll Seite 25 von 54 Version 1.0 vom 17.12.2020
- patients who have not yet recovered from acute toxicities of prior therapies
- claustrophobia
- pregnant or lactating women
- contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)
- participation in another competing clinical study or observation period of competing trials
Sites / Locations
- University Hospital of Heidelberg, Radiation OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
A
B
C
Magnetic Resonance-guided Stereotactic Body Radiotherapy (MRgSBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV
ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV
Magnetic Resonance-guided Stereotactic Body Radiotherapy (MRgSBRT). If a BED of ≥ 100 Gy cannot be achieved using an ITV concept (e.g. due to OAR constraints), patients will be treated in arm C using MRgSBRT with the highest achievable dose as deemed appropriate by the treating radiation oncologist