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
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
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
NCT ID
NCT03947268
First Posted
May 9, 2019
Last Updated
May 10, 2019
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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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