JOURNAL ONKOLOGIE – STUDIE

Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases

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

Rekrutierend

NCT-Nummer:
NCT06230666

Studienbeginn:
Februar 2024

Letztes Update:
13.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Matthias Guckenberger

Collaborator:
-

Studienlocations
(1 von 1)

Department of Radiation Oncology, University Hospital Zurich
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Indira Madani, MD, PhD
Phone: +41 44 255 37 68
E-Mail: indira.madani@usz.ch» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Treatment planning of SBRT for multiple metastases usually employs multiple isocenters, one

for each target, resulting in multiple treatment plans. Execution of such treatments requires

sequential multiple setups and treatment plan verifications. This practice complicates the

workflow of SBRT planning and delivery and makes target-by-target treatment lengthy and

patient compliance and comfort suboptimal. The investigators hypothesized that

single-isocenter SBRT for extracranial multiple metastases is non-inferior in terms of local

efficacy as compared to multiple-isocenter SBRT at the same radiation dose prescription.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Written informed consent according to Swiss law and ICH/GCP regulations signed and

dated by the participant and the investigator before any trial specific procedures

(Informed Consent Form);

- Distant extracranial metastases (lung, mediastinal/cervical lymph node, liver, bone

including spinal/paraspinal and abdominal/pelvic) from histologically confirmed

cancer;

- Distant metastases confirmed by imaging:

- CT is required in all cases;

- MRI is required for spinal and recommended for liver metastases;

- PET/CT is recommended for tumors showing high uptake of 18F-FDG, 11Ccholine,

68Ga- or 18F-PSMA;

- At least 2 distant metastases that are amendable to treat with a single isocenter

approach according to the judgment of the treating clinician;

- Patients who are willing and able to comply with scheduled visits, treatment, and

other trial procedures.

Exclusion Criteria:

- Prior radiotherapy for distant metastases if overlapping previous and current

treatment plans leads to excessive dose to OARs;

- Distant metastases with extension into the gastrointestinal tract, skin;

- Large inter-lesion distance and location of distant metastases in different organs

with different motion patterns;

- Women who are pregnant or breast feeding;

- Intention to become pregnant during the course of the trial;

- Lack of safe contraception, defined as: Female participants of childbearing potential,

not using and not willing to continue using a medically reliable method of

contraception for the entire study duration, such as oral, injectable, or implantable

contraceptives, or intrauterine contraceptive devices, or who are not using any other

method considered sufficiently reliable by the investigator in individual cases;

- Known or suspected non-compliance, drug or alcohol abuse;

- Inability to follow the procedures of the trial, e.g. due to language problems of the

participant;

- Enrolment of the investigator, his/her family members, employees and other dependent

persons.

Female participants who underwent hysterectomy and/or bilateral oophorectomy or

postmenopausal for longer than 2 years are not considered as being of child bearing

potential.

Studien-Rationale

Primary outcome:

1. Freedom from local disease progression at the site of treated metastases (Time Frame - 1 year post-SBRT):
Local control at the site of treated metastases

Secondary outcome:

1. Acute adverse events (AEs) (Time Frame - 3 months post-SBRT):
AEs occurring during SBRT and within 3 months post-SBRT

2. Late adverse events (AEs) (Time Frame - 12 months post-SBRT):
AEs occurring 3 months post-SBRT and later

3. Overall survival (Time Frame - 1 year post-SBRT):
The time from randomization to death from any cause

4. Progression-free survival (Time Frame - 1 year post-SBRT):
The time from randomization to cancer progression at any site or death, whichever comes first

5. Overall treatment time (Time Frame - During the procedure):
Time needed for setup, verification and beam-on

Studien-Arme

Experimental: Single-isocenter SBRT
SBRT using a single-isocenter treatment plan
Active Comparator: Multiple-isocenter SBRT
SBRT using multiple treatment plans

Geprüfte Regime

SBRT:
Stereotactic Body Radiation Therapy

Quelle: ClinicalTrials.gov

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