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Palliative Short Course Radiotherapy for Advanced Thoracic Cancer

Primary Purpose

Palliative Care

Status
Completed
Phase
Not Applicable
Locations
Italy
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, thoracic 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 thoracic 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

  • Radiation Oncology Center, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital

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.

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 the Common Terminology Criteria for Adverse Events (CTCAE). Values range from 1 (minimum acute toxicity) to 5 (maximum acute toxicity).
Quality of life
Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). Values range from 0 (better status) to 10 (worst status).
Pain relief
Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).
Late 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).

Full Information

First Posted
March 8, 2018
Last Updated
March 8, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT03465553
Brief Title
Palliative Short Course Radiotherapy for Advanced Thoracic Cancer
Official Title
Palliative Short Course Accelerated Radiation Therapy for Advanced Thoracic Cancer
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, 2018 (Actual)
Study Completion Date
January 1, 2018 (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 therapy in patients with symptomatic advanced thoracic cancer.
Detailed Description
The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy 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 advanced thoracic 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, thoracic 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
53 (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.
Intervention Type
Radiation
Intervention Name(s)
Short course radiotherapy
Intervention Description
An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer
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 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
Quality of life
Description
Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). Values range from 0 (better status) to 10 (worst status).
Time Frame
1 year
Title
Pain relief
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
Title
Late 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically proven advanced thoracic 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, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology Center, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital
City
Bologna
ZIP/Postal Code
40100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30298381
Citation
Farina E, Macchia G, Buwenge M, Siepe G, Zamagni A, Cammelli S, Cilla S, Wondemagegnhu T, Woldemariam AA, Uddin AFMK, Sumon MA, Cellini F, Deodato F, Morganti AG. Radiotherapy in palliation of thoracic tumors: a phase I-II study (SHARON project). Clin Exp Metastasis. 2018 Dec;35(8):739-746. doi: 10.1007/s10585-018-9942-6. Epub 2018 Oct 8.
Results Reference
derived

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Palliative Short Course Radiotherapy for Advanced Thoracic Cancer

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