Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases (SMILE)
Primary Purpose
Radiation Therapy, Bone Metastases, Pain
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Therapy
Eligibility 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.
Sites / Locations
- Kantonsspital WinterthurRecruiting
- University Hospital BernRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SBRT with 9 Gy x 3 fractions to the treatment site.
SBRT with 7 Gy x 5 fractions to the treatment site
Arm Description
Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site.
Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site.
Outcomes
Primary Outcome Measures
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05406063
First Posted
May 3, 2022
Last Updated
February 21, 2023
Sponsor
Kantonsspital Winterthur KSW
Collaborators
Krebsforschung Schweiz, Bern, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT05406063
Brief Title
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
Acronym
SMILE
Official Title
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Winterthur KSW
Collaborators
Krebsforschung Schweiz, Bern, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Therapy, Bone Metastases, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBRT with 9 Gy x 3 fractions to the treatment site.
Arm Type
Experimental
Arm Description
Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site.
Arm Title
SBRT with 7 Gy x 5 fractions to the treatment site
Arm Type
Active Comparator
Arm Description
Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
Stereotactic multiple fraction radiotherapy
Primary Outcome Measure Information:
Title
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.
Description
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.
Time Frame
Baseline and 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Foerster, MD
Phone
+4152 266 21 21
Email
robert.foerster@ksw.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Nidar Batifi, RN
Phone
+4152 266 21 21
Email
nidar.batifi@ksw.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Foerster, MD
Organizational Affiliation
Kantonsspital Winterthur KSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
Kanton Zürich
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Foerster, MD
Phone
+4152 266 21 21
Email
robert.foerster@ksw.ch
First Name & Middle Initial & Last Name & Degree
Nidar Batifi, RN
Phone
+41052 266 21 21
Email
nidar.batifi@ksw.ch
First Name & Middle Initial & Last Name & Degree
Robert Foerster, MD
First Name & Middle Initial & Last Name & Degree
Christina Schroeder, MD
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hossein Hemmatazad, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
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