๐ฌIn plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โค 5 cm (in case of 3 metastases: sum of diameters โค 12 cm)
* age โฅ 18 years of age
* Karnofsky Performance Score โฅ 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
๐
What it tests
- ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)
- MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.