Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases
Primary Purpose
Bone Metastases, Radiotherapy, Palliative Care
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
standard treatment
short course treatment
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastases focused on measuring Short Course Radiotherapy, Complicated Bone Metastases
Eligibility Criteria
Inclusion Criteria:
- complicated bone metastases from any solid tumor
- age >18 years
- ECOG performance status 0-3
- symptomatic lesion (NRS >1)
- no changes in analgesic treatment at least in the week before radiotherapy
Exclusion Criteria:
- pregnancy
- previously irradiation of the same region
Sites / Locations
- Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard treatment
short course treatment
Arm Description
Patients in this group are treated with 3000 cGy in 10 daily fractions
Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Outcomes
Primary Outcome Measures
Efficacy of palliation using the short course scheme compared with the standard scheme
Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)
Secondary Outcome Measures
Acute toxicity in the two treatment groups
incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria
Late toxicity in the two treatment groups
incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema
Quality of Life (QoL) assessment in the two groups
Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)
Full Information
NCT ID
NCT03503682
First Posted
April 9, 2018
Last Updated
April 19, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03503682
Brief Title
Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases
Official Title
SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
November 8, 2022 (Anticipated)
Study Completion Date
November 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases
Detailed Description
Standard treatment for complicated bone metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (4000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases, Radiotherapy, Palliative Care
Keywords
Short Course Radiotherapy, Complicated Bone Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard treatment
Arm Type
Active Comparator
Arm Description
Patients in this group are treated with 3000 cGy in 10 daily fractions
Arm Title
short course treatment
Arm Type
Experimental
Arm Description
Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Intervention Type
Radiation
Intervention Name(s)
standard treatment
Intervention Description
3000 cGy in 10 daily fractions
Intervention Type
Radiation
Intervention Name(s)
short course treatment
Intervention Description
2000 cGy in 4 fractions administered twice a day
Primary Outcome Measure Information:
Title
Efficacy of palliation using the short course scheme compared with the standard scheme
Description
Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Acute toxicity in the two treatment groups
Description
incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria
Time Frame
3 months
Title
Late toxicity in the two treatment groups
Description
incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time Frame
12 months
Title
Quality of Life (QoL) assessment in the two groups
Description
Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
complicated bone metastases from any solid tumor
age >18 years
ECOG performance status 0-3
symptomatic lesion (NRS >1)
no changes in analgesic treatment at least in the week before radiotherapy
Exclusion Criteria:
pregnancy
previously irradiation of the same region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessio G Morganti, MD
Phone
0512143564
Ext
+39
Email
alessio.morganti2@unibo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Organizational Affiliation
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Phone
0512143564
Ext
+39
Email
alessio.morganti2@unibo.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases
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