- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03525301
Short Course Radiation Therapy in Palliative Treatment of Brain Metastases
May 15, 2018 updated by: Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Standard treatment for brain metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BO
-
Bologna, BO, Italy, 40138
- Recruiting
- Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- symptomatic brain metastases from solid tumors
- age > 18 years
- ECOG performance status 0-3
- no changes in supportive care in the week before radiotherapy
Exclusion Criteria:
- pregnancy
- previous irradiation of the same region
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: short course treatment
patients in this group are treated with 1800 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
|
1800 cGy in 4 fractions administered twice a day
|
Active Comparator: standard treatment
patients in this group are treated with 3000 cGy in 10 daily fractions
|
3000 cGy in 10 daily fractions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of palliation using the short course scheme compared with the standard scheme
Time Frame: 3 months
|
Reduction of initial symptoms after radiotherapy, assessed with Likert scale (weakness, motor disorders, cognitive impairment, personality changes, loss of balance, seizures, changes in speech, vision, hearing, memory problems, nausea or vomiting are evaluated as none-mild-moderate-severe)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute toxicity in the two treatment groups
Time Frame: 3 months
|
Incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria
|
3 months
|
Late toxicity in the two treatment groups
Time Frame: 12 months
|
Incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema
|
12 months
|
Quality of Life (QoL) assessment in the two groups
Time Frame: 12 months
|
Changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2017
Primary Completion (Anticipated)
November 8, 2022
Study Completion (Anticipated)
November 8, 2023
Study Registration Dates
First Submitted
May 3, 2018
First Submitted That Met QC Criteria
May 3, 2018
First Posted (Actual)
May 15, 2018
Study Record Updates
Last Update Posted (Actual)
May 18, 2018
Last Update Submitted That Met QC Criteria
May 15, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RT-15-02 SHARON BRAIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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