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
Summary description of the study
Comparison of two irradiation schemes for the treatment of bone metastases outside the spine
(BASEC)
Intervention under investigation
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)
Disease under investigation
Bone metastases outside the spine
(BASEC)
Criteria for participation in trial
• Confirmed cancer diagnosis, • Presence of bone metastases, • Age ≥ 18 years (BASEC)
Exclusion criteria
• 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)
Exclusion criteria
• Prior irradiation of the intended treatment site • Lesions > 5 cm in maximum diameter, • Fracture at the intended treatment site (BASEC)
Trial sites
Bern, Winterthur
(BASEC)
Switzerland (ICTRP)
Sponsor
not available
Contact
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
03.05.2022
(BASEC)
ICTRP Trial ID
NCT05406063 (ICTRP)
Official title (approved by ethics committee)
not available
Academic title
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial (ICTRP)
Public title
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases (ICTRP)
Disease under investigation
Radiation TherapyBone MetastasesPain (ICTRP)
Intervention under investigation
Radiation: SBRT (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. (ICTRP)
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Krebsforschung Schweiz, Bern, Switzerland (ICTRP)
Additional contacts
Robert Foerster, MD;Robert Foerster, MD, robert.foerster@ksw.ch, +4152 266 21 21, Kantonsspital Winterthur KSW, (ICTRP)
Secondary trial IDs
2022-00631 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT05406063 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available