Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases
ConditionHepatic Metastasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
Stereotactic body radiotherapy (SBRT) is an established local treatment method for patients with hepatic oligometastases. Liver metastases often occur in close proximity to radiosensitive organs at risk (OARs). This limits the possibility to apply sufficiently high doses needed for optimal local control. MR-guided radiotherapy (MRgRT) is expected to hold potential to improve hepatic SBRT by offering superior soft-tissue contrast for enhanced target identification as well as the benefit of daily real-time adaptive treatment. The MAESTRO trial therefore aims to assess the potential advantages of adaptive, gated MR-guided SBRT (MRgSBRT) compared to conventional SBRT at a standard linac using an ITV (internal target volume) approach (ITV-SBRT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)
RadiationITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)
MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)
RadiationMRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: AExperimental treatment 1 intervention
Group B: BExperimental treatment 1 intervention
Group C: CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment related Toxicity
occurrence of treatment-related gastrointestinal or hepatobiliary CTCAE V5.0 toxicity of grade III or higher
Time frame
within the first year after radiation treatmentSecondary outcomes
1
Treatment related Toxicity
assesment of toxicity according to CTCAE V5.0 in all three treatment groups
Time frame
within 24 months after radiation treatment2
Treatment related Quality of life
Changes in quality of life according to EORTC QLQ C-30
Time frame
within 24 months after radiation treatment3
Treatment related Quality of life
Changes in quality of life according to EORTC QLQ LMC-21
Time frame
within 24 months after radiation treatment4
local Tumor Control
Change of local Tumor size at one specific site
Time frame
within 24 months after radiation treatmentSponsors and contacts
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Source ClinicalTrials.gov