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
Résumé de l'étude
Comparison of two irradiation schemes for the treatment of bone metastases outside the spine
(BASEC)
Intervention étudiée
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)
Maladie en cours d'investigation
Bone metastases outside the spine
(BASEC)
Critères de participation
• Confirmed cancer diagnosis, • Presence of bone metastases, • Age ≥ 18 years (BASEC)
Critères d'exclusion
• 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)
Critères d'exclusion
• Prior irradiation of the intended treatment site • Lesions > 5 cm in maximum diameter, • Fracture at the intended treatment site (BASEC)
Lieu de l’étude
Berne, Winterthur
(BASEC)
Switzerland (ICTRP)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Informations scientifiques
Kantonsspital Winterthur KSW,
+4152 266 21 21
robert.foerster@ksw.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
03.05.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05406063 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial (ICTRP)
Titre public
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases (ICTRP)
Maladie en cours d'investigation
Radiation TherapyBone MetastasesPain (ICTRP)
Intervention étudiée
Radiation: SBRT (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. (ICTRP)
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Krebsforschung Schweiz, Bern, Switzerland (ICTRP)
Contacts supplémentaires
Robert Foerster, MD;Robert Foerster, MD, robert.foerster@ksw.ch, +4152 266 21 21, Kantonsspital Winterthur KSW, (ICTRP)
ID secondaires
2022-00631 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT05406063 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible