Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Not Applicable

• Conditions: Bone Metastases; Palliative Care; Radiotherapy
• Interventions: Radiation: short course treatment; Radiation: standard treatment

• Registration Number: NCT03503682
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2017-11-08
• Status Verified: 2018-04
• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-19
• Last Update Submitted: 2018-04-19
• Study First Posted: 2018-04-20
• Last Update Posted: 2018-04-20
• Primary Completion: 2022-11-08
• Study Completion: 2023-11-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short course treatment	short course treatment	Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
standard treatment	standard treatment	Patients in this group are treated with 3000 cGy in 10 daily fractions

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital; 🇮🇹 Bologna, BO, Italy