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

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ClinicalTrials.gov Identifier: NCT05027711
Recruitment Status : Recruiting
First Posted : August 30, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

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).

Condition or disease Intervention/treatment Phase
Hepatic Metastasis Radiation: ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT) Radiation: MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases - MAESTRO -
Actual Study Start Date : August 12, 2021
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: A
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)
MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)

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

Experimental: C
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)
MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Treatment related Toxicity [ Time Frame: within 24 months after radiation treatment ]
    assesment of toxicity according to CTCAE V5.0 in all three treatment groups

  2. Treatment related Quality of life [ Time Frame: within 24 months after radiation treatment ]
    Changes in quality of life according to EORTC QLQ C-30

  3. Treatment related Quality of life [ Time Frame: within 24 months after radiation treatment ]
    Changes in quality of life according to EORTC QLQ LMC-21

  4. local Tumor Control [ Time Frame: within 24 months after radiation treatment ]
    Change of local Tumor size at one specific site

  5. locoregional control [ Time Frame: within 24 months after radiation treatment ]
    Change of local Tumor size within a defined local region

  6. distant tumor control [ Time Frame: within 24 months after radiation treatment ]
    apparence of distant Tumor leasions

  7. progression-free survival (PFS) [ Time Frame: 24 months after radiation treatment ]
    time of suvival without Tumor progression

  8. overall survival (OS) [ Time Frame: 24 months after radiation treatment ]
    time of Survival of studypopulation

  9. Changes in applied biological effective doses (BED) to the target Volumen (Tumor) [ Time Frame: through study completion, an average of 1 year ]
    BED increase and OAR doses with MRgSBRT compared to initial ITV-based planning in arms A and C

  10. Evaluation of potential prognostic biomarkers [ Time Frame: within 24 months after radiation treatment ]
    Changes in blood Levels of blood Parameters compared to reference samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≤ 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05027711


Contacts
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Contact: Juliane Hörner-Rieber, PD +496221 56 ext 2802 juliane.hörner-rieber@med.uni-heidelberg.de
Contact: Philipp Hoegen, MD +496221 56 ext 2802 philipp.hoegen@med.uni-heidelberg.de

Locations
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Germany
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Jürrgen Debus, MD PHD         
Sponsors and Collaborators
University Hospital Heidelberg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juergen Debus, Department Head, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT05027711    
Other Study ID Numbers: RADONK-MAESTRO-2020
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juergen Debus, University Hospital Heidelberg:
Magentic Resonance-guided Adaptive Stereotactic Body Radiotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases