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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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 26, 2018
    Last Updated
    March 8, 2018
    Sponsor
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
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    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

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    Short Course Radiotherapy in Complicated Bone Metastases Palliation

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