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Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer

Primary Purpose

Thoracic Cancer, Radiotherapy, Palliative Care

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
standard treatment
short course treatment
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 Thoracic Cancer focused on measuring Short Course Radiotherapy, Symptomatic thoracic lesions

Eligibility Criteria

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

Inclusion Criteria:

  • symptomatic thoracic malignant lesions (primary solid tumors or metastases from solid tumor)
  • age> 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
  • no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

  • pregnancy
  • previous irradiation of the same region

Sites / Locations

  • Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard treatment

short course treatment

Arm Description

patients in this group are treated with 3000 cGy in 10 daily fraction

patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Outcomes

Primary Outcome Measures

Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, coughing, dysphagia, dyspnea, brachial plexopathy, lymphedema)

Secondary Outcome Measures

acute toxicity in the two treatment groups
incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria (RTOG)
late toxicity in the two treatment groups
incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbility Scoring Schema
Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL
changes in QoL after the treatment assessed using EORTC questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the QoL of palliative cancer care patients)

Full Information

First Posted
January 11, 2019
Last Updated
January 14, 2019
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT03804307
Brief Title
Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer
Official Title
SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Thoracic Cancer: an Interventional, Randomized, Multicentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
November 8, 2022 (Anticipated)
Study Completion Date
November 8, 2023 (Anticipated)

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
No

5. Study Description

Brief Summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic thoracic malignant lesions
Detailed Description
Standard treatment for thoracic lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Cancer, Radiotherapy, Palliative Care
Keywords
Short Course Radiotherapy, Symptomatic thoracic lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard treatment
Arm Type
Active Comparator
Arm Description
patients in this group are treated with 3000 cGy in 10 daily fraction
Arm Title
short course treatment
Arm Type
Experimental
Arm Description
patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Intervention Type
Radiation
Intervention Name(s)
standard treatment
Intervention Description
3000 cGy in 10 daily fractions
Intervention Type
Radiation
Intervention Name(s)
short course treatment
Intervention Description
2000 cGy in 4 fractions administered twice a day
Primary Outcome Measure Information:
Title
Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
Description
reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, coughing, dysphagia, dyspnea, brachial plexopathy, lymphedema)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
acute toxicity in the two treatment groups
Description
incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria (RTOG)
Time Frame
3 months
Title
late toxicity in the two treatment groups
Description
incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbility Scoring Schema
Time Frame
12 months
Title
Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL
Description
changes in QoL after the treatment assessed using EORTC questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the QoL of palliative cancer care patients)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptomatic thoracic malignant lesions (primary solid tumors or metastases from solid tumor) age> 18 years Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 no changes in supportive care in the week before radiotherapy Exclusion Criteria: pregnancy previous irradiation of the same region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessio G Morganti, MD
Phone
0512143564
Ext
+39
Email
alessio.morganti2@unibo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Organizational Affiliation
Radiation Oncology Center, Dept of Experimental, Diagnostic and Speciality Medicine-DIMES, Unviersity of Bologna, S.Orsola-Malpighi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Phone
0512143564
Ext
+39
Email
alessio.morganti2@unibo.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer

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