Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Brain Metastases; Radiotherapy; Palliative Care

Treatments: Radiation: short course treatment; Radiation: standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03525301

RT-15-02 SHARON BRAIN

Details and patient eligibility

About

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

Full 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

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

standard treatment

Active Comparator group

Description:

patients in this group are treated with 3000 cGy in 10 daily fractions

Treatment:

Radiation: standard treatment

short course treatment

Experimental group

Description:

patients in this group are treated with 1800 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Treatment:

Radiation: short course treatment