Hepatic MetastasisPhase 2MAESTRONCT05027711
Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases
A Phase 2 study testing ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT) and MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy) in people with Hepatic Metastasis, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Metastasis
- What is being tested?
- ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT) and MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 12 Aug 2021to 31 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
Jürrgen Debus, MD PHD
About this study
Official title: Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases - MAESTRO -
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).
Read the detailed description
Hepatic SBRT is a well-established local treatment method for technically or medically inoperable hepatic metastases. However, clinicians are often restricted in the utilization of hepatic SBRT due to dose limitations of the uninvolved liver and nearby OARs (e.g. small bowel, stomach, kidney). MR-guided radiotherapy with its superior soft-tissue contrast is believed to facilitate the precise detection of tumor position and interfractional changes in patient anatomy. Respiratory gating at the MR-Linac enables real-time visualization of the tumor as well as synchronization of beam delivery to the patient's breathing . Therefore, safety margins and thus the irradiated volume can possibly be decreased with MRgSBRT in comparison to ITV-based SBRT, reducing the risk of treatment-associated toxicity. Hepatic MRgSBRT of smaller target volumes might further offer the possibility of dose escalation for increasing local control. To our knowledge, only two retrospective analyses including 26 and 29 patients as well as one case report about hepatic MR-guided SBRT using a MR-Linac can be found in literature. As MR-guided adaptive SBRT is very staff intense and time consuming compared to standard ITV-based SBRT, prospective studies are needed to demonstrate the expected benefits of MR-guided adaptive SBRT. This trial will be conducted as a prospective, randomized, three-armed phase II study in 82 patients with hepatic metastases (solid malignant tumor, 1-3 hepatic metastases confirmed by magnetic resonance imaging (MRI), maximum diameter of each metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12cm), age ≥ 18 years, Karnofsky Performance Score ≥ 60%). If a biologically effective dose (BED) ≥ 100 Gy is feasible based on ITV-based planning, patients will be randomized to either MRgSBRT (Arm A) or ITV-based SBRT (Arm B). If a lesion cannot be treated with a BED ≥ 100 Gy, the patient will be treated in Arm C with MRgSBRT at the highest possible dose.
- Conditions
- Hepatic Metastasis
- Being tested
- ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT), MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)
- Keywords
- Magentic Resonance-guided Adaptive Stereotactic Body Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Magnetic Resonance-guided Stereotactic Body Radiotherapy (MRgSBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV Receives: Radiation: MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy) |
| B | Experimental | ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV Receives: Radiation: ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT) |
| C | Experimental | 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 Receives: Radiation: MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related Toxicity
occurrence of treatment-related gastrointestinal or hepatobiliary CTCAE V5.0 toxicity of grade III or higher
Measured: within the first year after radiation treatment
Secondary outcomes (10)
Treatment related Toxicity
assesment of toxicity according to CTCAE V5.0 in all three treatment groups
Measured: within 24 months after radiation treatment
Treatment related Quality of life
Changes in quality of life according to EORTC QLQ C-30
Measured: within 24 months after radiation treatment
Treatment related Quality of life
Changes in quality of life according to EORTC QLQ LMC-21
Measured: within 24 months after radiation treatment
local Tumor Control
Change of local Tumor size at one specific site
Measured: within 24 months after radiation treatment
locoregional control
Change of local Tumor size within a defined local region
Measured: within 24 months after radiation treatment
distant tumor control
apparence of distant Tumor leasions
Measured: within 24 months after radiation treatment
progression-free survival (PFS)
time of suvival without Tumor progression
Measured: 24 months after radiation treatment
overall survival (OS)
time of Survival of studypopulation
Measured: 24 months after radiation treatment
Changes in applied biological effective doses (BED) to the target Volumen (Tumor)
BED increase and OAR doses with MRgSBRT compared to initial ITV-based planning in arms A and C
Measured: through study completion, an average of 1 year
Evaluation of potential prognostic biomarkers
Changes in blood Levels of blood Parameters compared to reference samples
Measured: within 24 months after radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start12 Aug 2021
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic MetastasisStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027711
- Sponsor's protocol ID
- RADONK-MAESTRO-2020
- Acronym
- MAESTRO
- Status last verified
- Mar 2026
- First submitted
- 3 Aug 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoegen P, Zhang KS, Tonndorf-Martini E, Weykamp F, Regnery S, Naumann P, Lang K, Ristau J, Korber SA, Dreher C, Buchele C, Rippke C, Renkamp CK, Paul KM, Konig L, Busch C, Krisam J, Sedlaczek O, Schlemmer HP, Niyazi M, Corradini S, Debus J, Kluter S, Horner-Rieber J. MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial. Radiat Oncol. 2022 Mar 27;17(1):59. doi: 10.1186/s13014-022-02033-2.
PubMed 35346270
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases - MAESTRO -
- ClinicalTrials.gov ID
- NCT05027711
- Acronym / sponsor ID
- MAESTRO / RADONK-MAESTRO-2020
- Conditions
- Hepatic Metastasis
- Keywords
- Magentic Resonance-guided Adaptive Stereotactic Body Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Hepatic SBRT is a well-established local treatment method for technically or medically inoperable hepatic metastases. However, clinicians are often restricted in the utilization of hepatic SBRT due to dose limitations of the uninvolved liver and nearby OARs (e.g. small bowel, stomach, kidney). MR-guided radiotherapy with its superior soft-tissue contrast is believed to facilitate the precise detection of tumor position and interfractional changes in patient anatomy. Respiratory gating at the MR-Linac enables real-time visualization of the tumor as well as synchronization of beam delivery to the patient's breathing . Therefore, safety margins and thus the irradiated volume can possibly be decreased with MRgSBRT in comparison to ITV-based SBRT, reducing the risk of treatment-associated toxicity. Hepatic MRgSBRT of smaller target volumes might further offer the possibility of dose escalation for increasing local control. To our knowledge, only two retrospective analyses including 26 and 29 patients as well as one case report about hepatic MR-guided SBRT using a MR-Linac can be found in literature. As MR-guided adaptive SBRT is very staff intense and time consuming compared to standard ITV-based SBRT, prospective studies are needed to demonstrate the expected benefits of MR-guided adaptive SBRT. This trial will be conducted as a prospective, randomized, three-armed phase II study in 82 patients with hepatic metastases (solid malignant tumor, 1-3 hepatic metastases confirmed by magnetic resonance imaging (MRI), maximum diameter of each metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12cm), age ≥ 18 years, Karnofsky Performance Score ≥ 60%). If a biologically effective dose (BED) ≥ 100 Gy is feasible based on ITV-based planning, patients will be randomized to either MRgSBRT (Arm A) or ITV-based SBRT (Arm B). If a lesion cannot be treated with a BED ≥ 100 Gy, the patient will be treated in Arm C with MRgSBRT at the highest possible dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Radiation: MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)Magnetic Resonance-guided Stereotactic Body Radiotherapy (MRgSBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV |
| B | Experimental | Radiation: ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV |
| C | Experimental | Radiation: MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT) | Radiation | B |
| MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy) | Radiation | A, C |
Primary outcome
Treatment related Toxicity
Time frame: within the first year after radiation treatment
occurrence of treatment-related gastrointestinal or hepatobiliary CTCAE V5.0 toxicity of grade III or higher
10 secondary outcomes
Treatment related Toxicity
Time frame: within 24 months after radiation treatment
Treatment related Quality of life
Time frame: within 24 months after radiation treatment
Treatment related Quality of life
Time frame: within 24 months after radiation treatment
local Tumor Control
Time frame: within 24 months after radiation treatment
locoregional control
Time frame: within 24 months after radiation treatment
distant tumor control
Time frame: within 24 months after radiation treatment
progression-free survival (PFS)
Time frame: 24 months after radiation treatment
overall survival (OS)
Time frame: 24 months after radiation treatment
Changes in applied biological effective doses (BED) to the target Volumen (Tumor)
Time frame: through study completion, an average of 1 year
Evaluation of potential prognostic biomarkers
Time frame: within 24 months after radiation treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 35346270Hoegen P, Zhang KS, Tonndorf-Martini E, Weykamp F, Regnery S, Naumann P, Lang K, Ristau J, Korber SA, Dreher C, Buchele C, Rippke C, Renkamp CK, Paul KM, Konig L, Busch C, Krisam J, Sedlaczek O, Schlemmer HP, Niyazi M, Corradini S, Debus J, Kluter S, Horner-Rieber J. MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial. Radiat Oncol. 2022 Mar 27;17(1):59. doi: 10.1186/s13014-022-02033-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT) and MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy) in people with Hepatic Metastasis, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Liermann, PD Dr (+496221 56, jakob.liermann@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related Toxicity (time frame: within the first year after radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.