Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05027711

Studienbeginn:
August 2021

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Liver Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Kontakt

Juliane Hörner-Rieber, PD
Kontakt:
Phone: +496221 56
Phone (ext.): 2802
E-Mail: juliane.hörner-rieber@med.uni-heidelberg.de» Kontaktdaten anzeigen

Philipp Hoegen, MD
Kontakt:
Phone: +496221 56
Phone (ext.): 2802
E-Mail: philipp.hoegen@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Heidelberg, Radiation Oncology
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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

Studien-Arme

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

Geprüfte Regime

ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT):
ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)
MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy):
MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)

Quelle: ClinicalTrials.gov

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