NCT05027711

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
45mo left

Started Aug 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Aug 2021Jan 2030

First Submitted

Initial submission to the registry

August 3, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

August 12, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2030

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

7.5 years

First QC Date

August 3, 2021

Last Update Submit

March 6, 2026

Conditions

Hepatic Metastasis

Keywords

Magentic Resonance-guided Adaptive Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Treatment related Toxicity

    occurrence of treatment-related gastrointestinal or hepatobiliary CTCAE V5.0 toxicity of grade III or higher

    within the first year after radiation treatment

Secondary Outcomes (10)

  • Treatment related Toxicity

    within 24 months after radiation treatment

  • Treatment related Quality of life

    within 24 months after radiation treatment

  • Treatment related Quality of life

    within 24 months after radiation treatment

  • local Tumor Control

    within 24 months after radiation treatment

  • locoregional control

    within 24 months after radiation treatment

  • +5 more secondary outcomes

Study Arms (3)

A

EXPERIMENTAL

Magnetic Resonance-guided Stereotactic Body Radiotherapy (MRgSBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV

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

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

Radiation: MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)

Interventions

MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)RADIATION

MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)

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

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35346270DERIVED

Central Study Contacts

Jakob Liermann, PD Dr

CONTACT

+496221 56jakob.liermann@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Head

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 30, 2021

Study Start

August 12, 2021

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2030

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)