Back to results2D-radiotherapy in Palliation of Advanced Esophageal Cancer (SHARON-2D)
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, radiotherapy, pain, quality of life, esophageal cancer
Eligibility Criteria
Inclusion Criteria:
- histologically proven advanced esophageal 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 and 2D-technique.
Outcomes
Primary Outcome Measures
Assessment of symptoms [odynophagia, chest-back pain, dysphagia, regurgitation]
Symptoms were graded using the IAEA scoring system. Values range from 0 (no symptom) to 4 (severe symptom).
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
Acute toxicity after treatment is evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Values range from 0 (no acute toxicity) to 4 (maximum acute toxicity).
Assessment of the Performance Status
Performance Status after the treatment is evaluated according with the Eastern Cooperative Oncology Group (ECOG) score. Values range from 0 (better status) to 5 (worst status).
Assessment of the Overall Survival
Overall Survival is evaluated from the end of radiotherapy to the last date of follow-up. It is calculated in months.
Full Information
NCT ID
NCT03922152
First Posted
April 17, 2019
Last Updated
September 12, 2019
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03922152
Brief Title
2D-radiotherapy in Palliation of Advanced Esophageal Cancer
Acronym
SHARON-2D
Official Title
Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 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 efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal cancer.
Detailed Description
The study wants to define the efficacy of a short course accelerated 2D-radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced esophageal 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, radiotherapy, pain, quality of life, esophageal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (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 and 2D-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 esophageal cancer.
Primary Outcome Measure Information:
Title
Assessment of symptoms [odynophagia, chest-back pain, dysphagia, regurgitation]
Description
Symptoms were graded using the IAEA scoring system. Values range from 0 (no symptom) to 4 (severe symptom).
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 Radiation Therapy Oncology Group (RTOG) scale. Values range from 0 (no acute toxicity) to 4 (maximum acute toxicity).
Time Frame
1 year
Title
Assessment of the Performance Status
Description
Performance Status after the treatment is evaluated according with the Eastern Cooperative Oncology Group (ECOG) score. Values range from 0 (better status) to 5 (worst status).
Time Frame
1 year
Title
Assessment of the Overall Survival
Description
Overall Survival is evaluated from the end of radiotherapy to the last date of follow-up. It is calculated in months.
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 esophageal 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, DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
2D-radiotherapy in Palliation of Advanced Esophageal Cancer
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