Short Course Radiotherapy in Complicated Bone Metastases Palliation

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455231
• Other study ID #: SHARON-BONE
• Status: Completed
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 8, 2018
• Start date: January 1, 2009
• Est. completion date: January 1, 2017

Study information

• Verified date: March 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Palliative Care

Intervention

Radiation:
• Short course radiotherapy
An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with complicated bone metastases

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose	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	1 year
Secondary	Acute toxicity	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).	1 year
Secondary	Quality of life	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).	1 year
Secondary	Pain relief	Pain after the therapy is evaluated with the visual analogically scale (VAS scale). Values range from 0 (no pain) to 10 (worst possible pain).	1 year
Secondary	Late toxicity	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	1 year