Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03503682

Enrollment

Registered

2018-04-20

Start date

2017-11-08

Completion date

2023-11-08

Last updated

2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Palliative Care, Radiotherapy

Keywords

Short Course Radiotherapy, Complicated Bone Metastases

Brief summary

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

Detailed 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.

Interventions

RADIATIONstandard treatment

3000 cGy in 10 daily fractions

RADIATIONshort course treatment

2000 cGy in 4 fractions administered twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of palliation using the short course scheme compared with the standard scheme	3 months	Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)

Secondary

Measure	Time frame	Description
Acute toxicity in the two treatment groups	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	12 months	incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema
Quality of Life (QoL) assessment in the two groups	12 months	Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)

Countries

Italy

Contacts

Primary ContactAlessio G Morganti, MD

alessio.morganti2@unibo.it0512143564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026