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Radiotherapy in Palliation of Advanced Pelvic Cancer

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, pelvic cancer, radiotherapy, pain, Quality of life

Eligibility Criteria

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

Inclusion Criteria:

  • histologically proven advanced pelvic cancer
  • excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
  • age > 18 years
  • Eastern Cooperative Oncology Group (ECOG) <3

Exclusion Criteria:

- prior radiotherapy 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 2 days with accelerated hypo-fractionation technique.

    Outcomes

    Primary Outcome Measures

    Assessment of symptoms [pain]
    Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).

    Secondary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
    Acute toxicity after treatment is evaluated with the Common Terminology Criteria for Adverse Events (CTCAE). Values range from 1 (minimum acute toxicity) to 5 (maximum acute toxicity).
    Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity]
    Late toxicity after the treatment is evaluated with the Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC). Values range from 1 (minimum late toxicity) to 5 (maximum/severe late toxicity).
    Assessment of the Quality of life (QOL)
    Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). CLAS scale evaluates well-being, fatigue, and ability to perform daily activities. This method is based on a linear analogue scale. Values range from 0 (better status) to 10 (worst status).

    Full Information

    First Posted
    May 9, 2019
    Last Updated
    May 10, 2019
    Sponsor
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03947268
    Brief Title
    Radiotherapy in Palliation of Advanced Pelvic Cancer
    Official Title
    Palliative Short-course Radiotherapy in Advanced Pelvic Cancer: a Phase II Study (SHARON Project)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2009 (Actual)
    Primary Completion Date
    January 1, 2019 (Actual)
    Study Completion Date
    January 1, 2019 (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 safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer.
    Detailed Description
    he study wants to define the safety and efficacy of a short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced solid cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Palliative Care
    Keywords
    palliative care, pelvic cancer, 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
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Short-course radiotherapy
    Arm Type
    Experimental
    Arm Description
    The radiotherapy is delivered over 2 days with accelerated hypo-fractionation technique.
    Intervention Type
    Radiation
    Intervention Name(s)
    Short course radiotherapy
    Intervention Description
    An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced pelvic cancer.
    Primary Outcome Measure Information:
    Title
    Assessment of symptoms [pain]
    Description
    Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).
    Time Frame
    1 year]
    Secondary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
    Description
    Acute toxicity after treatment is evaluated with the Common Terminology Criteria for Adverse Events (CTCAE). Values range from 1 (minimum acute toxicity) to 5 (maximum acute toxicity).
    Time Frame
    1 year
    Title
    Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity]
    Description
    Late toxicity after the treatment is evaluated with the Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC). Values range from 1 (minimum late toxicity) to 5 (maximum/severe late toxicity).
    Time Frame
    1 year
    Title
    Assessment of the Quality of life (QOL)
    Description
    Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). CLAS scale evaluates well-being, fatigue, and ability to perform daily activities. This method is based on a linear analogue scale. Values range from 0 (better status) to 10 (worst status).
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: histologically proven advanced pelvic cancer excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status age > 18 years Eastern Cooperative Oncology Group (ECOG) <3 Exclusion Criteria: - prior radiotherapy to the same region
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alessio G. Morganti, MD
    Organizational Affiliation
    Radiation Oncology Center, S.Orsola-Malpighi Hospital, Bologna, Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Radiotherapy in Palliation of Advanced Pelvic Cancer

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