SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Thoracic Cancer: an Interventional, Randomized, Multicentric Study

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country72 target enrollmentNovember 8, 2017

ConditionsThoracic Cancer Radiotherapy Palliative Care

Overview

Phase: N/A
Intervention: Not specified
Conditions: Thoracic Cancer
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment: 72
Locations: 1
Primary Endpoint: Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 8, 2017

End Date

November 8, 2023

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Responsible Party

Principal Investigator

Alessio Giuseppe Morganti

Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Outcomes

Primary Outcomes

Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale

Time Frame: 3 months

reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, coughing, dysphagia, dyspnea, brachial plexopathy, lymphedema)

Secondary Outcomes

acute toxicity in the two treatment groups(3 months)
late toxicity in the two treatment groups(12 months)
Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL(12 months)