- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03503682
Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases
April 19, 2018 updated by: Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study
Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BO
-
Bologna, BO, Italy, 40138
- Recruiting
- Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard treatment
Patients in this group are treated with 3000 cGy in 10 daily fractions
|
3000 cGy in 10 daily fractions
|
Experimental: short course treatment
Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
|
2000 cGy in 4 fractions administered twice a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of palliation using the short course scheme compared with the standard scheme
Time Frame: 3 months
|
Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute toxicity in the two treatment groups
Time Frame: 3 months
|
incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria
|
3 months
|
Late toxicity in the two treatment groups
Time Frame: 12 months
|
incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema
|
12 months
|
Quality of Life (QoL) assessment in the two groups
Time Frame: 12 months
|
Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2017
Primary Completion (Anticipated)
November 8, 2022
Study Completion (Anticipated)
November 8, 2023
Study Registration Dates
First Submitted
April 9, 2018
First Submitted That Met QC Criteria
April 19, 2018
First Posted (Actual)
April 20, 2018
Study Record Updates
Last Update Posted (Actual)
April 20, 2018
Last Update Submitted That Met QC Criteria
April 19, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RT-15-06 SHARON BONE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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