HumRes60606
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SNCTP000004897
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BASEC2022-00631
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NCT05406063
Stereotactic multiple fractions radiotherapy for non-spinal bone metastases
Descrizione riassuntiva dello studio
Comparison of two irradiation schemes for the treatment of bone metastases outside the spine
(BASEC)
Intervento studiato
We want to investigate in this study whether high-precision radiotherapy over 3 sessions with 9 Gy per session within one week is as effective as high-precision radiotherapy over 5 sessions with 7 Gy per session within one week.
(BASEC)
Malattie studiate
Bone metastases outside the spine
(BASEC)
Criteri di partecipazione
• Confirmed cancer diagnosis, • Presence of bone metastases, • Age ≥ 18 years (BASEC)
Criteri di esclusione
• Prior irradiation of the intended treatment site • Lesions > 5 cm in maximum diameter, • Fracture at the intended treatment site (BASEC)
• Confirmed cancer diagnosis, • Presence of bone metastases, • Age ≥ 18 years (BASEC)
Criteri di esclusione
• Prior irradiation of the intended treatment site • Lesions > 5 cm in maximum diameter, • Fracture at the intended treatment site (BASEC)
Luogo dello studio
Berna, Winterthur
(BASEC)
Switzerland (ICTRP)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Informazioni scientifiche
Kantonsspital Winterthur KSW,
+4152 266 21 21
robert.foerster@ksw.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
03.05.2022
(BASEC)
ID di studio ICTRP
NCT05406063 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial (ICTRP)
Titolo pubblico
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases (ICTRP)
Malattie studiate
Radiation TherapyBone MetastasesPain (ICTRP)
Intervento studiato
Radiation: SBRT (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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. (ICTRP)
non disponibile
Endpoint primari e secondari
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. (ICTRP)
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Krebsforschung Schweiz, Bern, Switzerland (ICTRP)
Contatti aggiuntivi
Robert Foerster, MD;Robert Foerster, MD, robert.foerster@ksw.ch, +4152 266 21 21, Kantonsspital Winterthur KSW, (ICTRP)
ID secondari
2022-00631 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05406063 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile