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Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Tracking Information
First Submitted Date  ICMJE May 3, 2018
First Posted Date  ICMJE May 15, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE November 8, 2017
Estimated Primary Completion Date November 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
  • 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
  • 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
  • QUality of Life (QoL) assessment in the two groups [ Time Frame: 12 months ]
    Changes in QoL after the treatment assessed using EORTC questionnaire C15-PAL
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Course Radiation Therapy in Palliative Treatment of Brain Metastases
Official Title  ICMJE SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Metastases
  • Radiotherapy
  • Palliative Care
Intervention  ICMJE
  • Radiation: standard treatment
    3000 cGy in 10 daily fractions
  • Radiation: short course treatment
    1800 cGy in 4 fractions administered twice a day
Study Arms  ICMJE
  • Active Comparator: standard treatment
    patients in this group are treated with 3000 cGy in 10 daily fractions
    Intervention: Radiation: standard 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)
    Intervention: Radiation: short course treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2018)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 8, 2023
Estimated Primary Completion Date November 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alessio G Morganti, MD 0512143564 ext +39 alessio.morganti2@unibo.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03525301
Other Study ID Numbers  ICMJE RT-15-02 SHARON BRAIN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Sponsor  ICMJE IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account IRCCS Azienda Ospedaliero-Universitaria di Bologna
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP