Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

Brain Metastases Clinical Trial

Official title:

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03525301
• Other study ID #: RT-15-02 SHARON BRAIN
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: November 8, 2023

Study information

• Verified date: May 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Alessio G Morganti, MD
• Phone: 0512143564
• Email: alessio.morganti2[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Palliative Care
• Radiotherapy

Intervention

Radiation:
• standard treatment
3000 cGy in 10 daily fractions
• short course treatment
1800 cGy in 4 fractions administered twice a day

Locations

Country	Name	City	State
Italy	Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of palliation using the short course scheme compared with the standard scheme	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	Acute toxicity in the two treatment groups	Incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria	3 months
Secondary	Late toxicity in the two treatment groups	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
Secondary	Quality of Life (QoL) assessment in the two groups	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