Short Course Radiotherapy in Complicated Bone Metastases Palliation

Short Course Accelerated Radiation Therapy (Sharon) in Complicated Bone Metastases Palliation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03455231

Enrollment

Registered

2018-03-06

Start date

2009-01-01

Completion date

2017-01-01

Last updated

2018-03-12

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

Conditions

Palliative Care

Keywords

palliative care, complicated bone metastases, radiotherapy, pain, quality of life

Brief summary

The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with complicated bone metastases.

Detailed description

The study wants to define the maximum tolerated dose (MTD) of a conformal short course radiation treatment delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of complicated bone metastases.

Interventions

RADIATIONShort course radiotherapy

An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with complicated bone metastases

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* radiologically proven complicated bone metastasis * age \> 18 years * Eastern Cooperative Oncology Group (ECOG) performance status \< 3

Exclusion criteria

* prior RT to the same region

Design outcomes

Primary

Measure	Time frame	Description
Maximum tolerated dose	1 year	The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients

Secondary

Measure	Time frame	Description
Acute toxicity	1 year	Acute toxicity after treatment is evaluated with Common Terminology Criteria for Adverse Events (CTCAE) scale (values from 1 that represents the minimum acute toxicity to 5 that represent the maximum/severe acute toxicity).
Quality of life	1 year	Quality of life after treatment is evaluated according to Cancer Lineal Analog Scale (CLAS) which evaluated well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one).
Pain relief	1 year	Pain after the therapy is evaluated with the visual analogically scale (VAS scale). Values range from 0 (no pain) to 10 (worst possible pain).
Late toxicity	1 year	Late toxicity after treatment is evaluated with Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (EORTC-RTOG scale). The values range from 1 that represents the minimum late toxicity to 5 that represent the maximum/severe late toxicity

Outcome results

None listed

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