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Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

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ClinicalTrials.gov Identifier: NCT03525301
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Alessio Giuseppe Morganti, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief Summary:
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors

Condition or disease Intervention/treatment Phase
Brain Metastases Radiotherapy Palliative Care Radiation: standard treatment Radiation: short course treatment Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : November 8, 2022
Estimated Study Completion Date : November 8, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Active Comparator: standard treatment
patients in this group are treated with 3000 cGy in 10 daily fractions
Radiation: standard treatment
3000 cGy in 10 daily fractions

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)
Radiation: short course treatment
1800 cGy in 4 fractions administered twice a day




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525301


Contacts
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Contact: Alessio G Morganti, MD 0512143564 ext +39 alessio.morganti2@unibo.it

Locations
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Italy
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital Recruiting
Bologna, BO, Italy, 40138
Contact: Alessio G Morganti, MD    0512143564 ext +39    alessio.morganti2@unibo.it   
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: Alessio G Morganti, MD Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

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Responsible Party: Alessio Giuseppe Morganti, Professor, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03525301     History of Changes
Other Study ID Numbers: RT-15-02 SHARON BRAIN
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessio Giuseppe Morganti, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Short Course Radiotherapy
Symptomatic brain metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases