RecruitingPhase 2NCT05027711

Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases

Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases - MAESTRO -

Sponsor

University Hospital Heidelberg

Enrollment

90 participants

Start Date

Aug 12, 2021

Study Type

INTERVENTIONAL

Conditions

Hepatic Metastasis

Summary

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

Min Age: 18 Years

Inclusion Criteria11

confirmed underlying solid malignant tumor (no germ cell tumor, leukemia, lymphoma)
-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 Criteria11

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

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Interventions

RADIATIONITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)

ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)

RADIATIONMRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)

MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)

Locations(1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, Germany

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NCT05027711