Short Course Radiotherapy in Complicated Bone Metastases Palliation
Primary Purpose
Palliative Care
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short course radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Palliative Care focused on measuring palliative care, complicated bone metastases, radiotherapy, pain, quality of life
Eligibility Criteria
Inclusion Criteria:
- radiologically proven complicated bone metastasis
- age > 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status < 3
Exclusion Criteria:
- prior RT to the same region
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Short course radiotherapy
Arm Description
The radiotherapy is delivered over two days with accelerated hypo-fractionation
Outcomes
Primary Outcome Measures
Maximum tolerated dose
The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients
Secondary Outcome Measures
Acute toxicity
Acute toxicity after treatment is evaluated with Common Terminology Criteria for Adverse Events (CTCAE) scale (values from 1 that represents the minimum acute toxicity to 5 that represent the maximum/severe acute toxicity).
Quality of life
Quality of life after treatment is evaluated according to Cancer Lineal Analog Scale (CLAS) which evaluated well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one).
Pain relief
Pain after the therapy is evaluated with the visual analogically scale (VAS scale). Values range from 0 (no pain) to 10 (worst possible pain).
Late toxicity
Late toxicity after treatment is evaluated with Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (EORTC-RTOG scale). The values range from 1 that represents the minimum late toxicity to 5 that represent the maximum/severe late toxicity
Full Information
NCT ID
NCT03455231
First Posted
February 26, 2018
Last Updated
March 8, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03455231
Brief Title
Short Course Radiotherapy in Complicated Bone Metastases Palliation
Official Title
Short Course Accelerated Radiation Therapy (Sharon) in Complicated Bone Metastases Palliation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)
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
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with complicated bone metastases.
Detailed Description
The study wants to define the maximum tolerated dose (MTD) of a conformal short course radiation treatment delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of complicated bone metastases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Care
Keywords
palliative care, complicated bone metastases, radiotherapy, pain, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short course radiotherapy
Arm Type
Experimental
Arm Description
The radiotherapy is delivered over two days with accelerated hypo-fractionation
Intervention Type
Radiation
Intervention Name(s)
Short course radiotherapy
Intervention Description
An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with complicated bone metastases
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acute toxicity
Description
Acute toxicity after treatment is evaluated with Common Terminology Criteria for Adverse Events (CTCAE) scale (values from 1 that represents the minimum acute toxicity to 5 that represent the maximum/severe acute toxicity).
Time Frame
1 year
Title
Quality of life
Description
Quality of life after treatment is evaluated according to Cancer Lineal Analog Scale (CLAS) which evaluated well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one).
Time Frame
1 year
Title
Pain relief
Description
Pain after the therapy is evaluated with the visual analogically scale (VAS scale). Values range from 0 (no pain) to 10 (worst possible pain).
Time Frame
1 year
Title
Late toxicity
Description
Late toxicity after treatment is evaluated with Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (EORTC-RTOG scale). The values range from 1 that represents the minimum late toxicity to 5 that represent the maximum/severe late toxicity
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
radiologically proven complicated bone metastasis
age > 18 years
Eastern Cooperative Oncology Group (ECOG) performance status < 3
Exclusion Criteria:
prior RT to the same region
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessio G. Morganti, MD
Organizational Affiliation
Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30121938
Citation
Capuccini J, Macchia G, Farina E, Buwenge M, Genovesi D, Caravatta L, Nguyen NP, Cammelli S, Cilla S, Wondemagegnhu T, Uddin AFMK, Aziz Sumon M, Cellini F, Valentini V, Deodato F, Morganti AG. Short-course regimen of palliative radiotherapy in complicated bone metastases: a phase i-ii study (SHARON Project). Clin Exp Metastasis. 2018 Oct;35(7):605-611. doi: 10.1007/s10585-018-9931-9. Epub 2018 Aug 18.
Results Reference
derived
Learn more about this trial
Short Course Radiotherapy in Complicated Bone Metastases Palliation
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