Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Radiotherapy; Palliative Care; Bone Metastases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03503682

RT-15-06 SHARON BONE

Details and patient eligibility

About

Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases

Full description

Standard treatment for complicated bone metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (4000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• complicated bone metastases from any solid tumor
• age >18 years
• ECOG performance status 0-3
• symptomatic lesion (NRS >1)
• no changes in analgesic treatment at least in the week before radiotherapy

Exclusion criteria

• pregnancy
• previously irradiation of the same region

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 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 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Treatment:

Radiation: short course treatment