Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

Rekrutierend

NCT-Nummer:
NCT05406063

Studienbeginn:
Juni 2022

Letztes Update:
03.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Bone Neoplasms, Bone Marrow Diseases

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kantonsspital Winterthur KSW

Collaborator:
Krebsforschung Schweiz, Bern, Switzerland

Studienleiter

Robert Foerster, MD
Principal Investigator
Kantonsspital Winterthur KSW

Kontakt

Robert Foerster, MD
Kontakt:
Phone: +4152 266 21 21
E-Mail: robert.foerster@ksw.ch» Kontaktdaten anzeigen

Nidar Batifi, RN
Kontakt:
Phone: +4152 266 21 21
E-Mail: nidar.batifi@ksw.ch» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Kantonsspital Winterthur
8401 Winterthur
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Robert Foerster, MD
Phone: +4152 266 21 21
E-Mail: robert.foerster@ksw.ch

Nidar Batifi, RN
Phone: +41052 266 21 21
E-Mail: nidar.batifi@ksw.ch» Ansprechpartner anzeigen

University Hospital Bern
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Hossein Hemmatazad, MD» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

To investigate, whether multi-fraction stereotactic body radiation therapy (SBRT) within 3

treatment fractions is non-inferior to the current standard of care of 5 fraction SBRT

regarding pain response at 3 months after radiotherapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Personally signed and dated written informed consent,

- Histological diagnosis of malignancy,

- Histologically or radiologically diagnosed bone metastasis,

- Age ≥ 18 years

- Pain or under pain control medication

Exclusion Criteria:

- Pregnant or lactating women,

- Women of childbearing potential or sexually active males not willing to use effective

contraception while on treatment and 3 months after the end of treatment,

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

psychological disorders, dementia, etc.,

- Prior radiotherapy to the intended treatment site,

- Lesions > 5cm in maximum diameter,

- Prior treatment with radioactive isotopes within 30 days of randomisation,

- Spinal column, hands, feet, or head as intended treatment site,- Fracture at the

intended treatment site,

- Surgery required or previous surgery at the intended treatment site

- Instability of the intended treatment site.

Studien-Rationale

Primary outcome:

1. Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. (Time Frame - Baseline and 3 months after treatment):
The Visual Analog Scale is a validated, subjective measure for pain. Possible scores ranges between zero (no pain) and ten (worst possible pain). The primary endpoint was defined as pain relief > 2 points from Baseline to 3 months after treatment.

Studien-Arme

Experimental: SBRT with 9 Gy x 3 fractions to the treatment site.
Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site.
Active Comparator: SBRT with 7 Gy x 5 fractions to the treatment site
Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site.

Geprüfte Regime

SBRT:
Stereotactic multiple fraction radiotherapy

Quelle: ClinicalTrials.gov