Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03503682
• Other study ID #: RT-15-06 SHARON BONE
• Status: Recruiting
• Phase: N/A
• First received: April 9, 2018
• Last updated: April 19, 2018
• Start date: November 8, 2017
• Est. completion date: November 8, 2023

Study information

• Verified date: April 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Alessio G Morganti, MD
• Phone: 0512143564
• Email: alessio.morganti2[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Palliative Care
• Radiotherapy

Intervention

Radiation:
• standard treatment
3000 cGy in 10 daily fractions
• short course treatment
2000 cGy in 4 fractions administered twice a day

Locations

Country	Name	City	State
Italy	Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital	Bologna	BO

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of palliation using the short course scheme compared with the standard scheme	Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)	3 months
Secondary	Acute toxicity in the two treatment groups	incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria	3 months
Secondary	Late toxicity in the two treatment groups	incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema	12 months
Secondary	Quality of Life (QoL) assessment in the two groups	Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)	12 months