CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 90 target
Drug / intervention
ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT) +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 9
  • Confirmed solid malignant tumor (excluding germ cell, leukemia, lymphoma)
  • 1-3 hepatic metastases confirmed by pre-therapeutic MRI
  • Indication for SBRT of 1-3 hepatic metastases
  • Maximum diameter each metastasis ≤5 cm; if 3 metastases sum of diameters ≤12 cm
Key exclusion· 10
  • Primary liver cancer (HCC, CCC)
  • History of liver transplantation
  • Impairment of liver function contraindicating radiotherapy
  • Active acute hepatic/biliary infection (hepatitis, cholangitis, cholecystitis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05027711
NCT05027711Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting

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

University Hospital Heidelberg·interventional·Posted Aug 30, 2021·Updated Mar 10, 2026

In Brief

A Phase 2 clinical trial evaluating ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT) and MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy) for Hepatic Metastasis. Currently recruiting, targeting 90 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 2Recruiting
202220232024202520262027202820292030
First PostedAug 30, 2021
Enrollment StartAug 12, 2021
Primary CompletionJan 31, 2029
Study CompletionJan 31, 2030
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 4.8 years agoPrimary completion in 2.6 years

Interventions

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

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

MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)radiation

MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)