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Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Primary Purpose

Bone Metastases, Radiotherapy, Palliative Care

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

standard treatment

short course treatment

About this trial

This is an interventional treatment trial for Bone Metastases focused on measuring Short Course Radiotherapy, Complicated Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard treatment

short course treatment

Arm Description

Patients in this group are treated with 3000 cGy in 10 daily fractions

Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Outcomes

Primary Outcome Measures

Efficacy of palliation using the short course scheme compared with the standard scheme

Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)

Secondary Outcome Measures

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

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

Quality of Life (QoL) assessment in the two groups

Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)

Full Information

NCT ID

NCT03503682

First Posted

April 9, 2018

Last Updated

April 19, 2018

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT03503682

Brief Title

Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Recruiting

Study Start Date

November 8, 2017 (Actual)

Primary Completion Date

November 8, 2022 (Anticipated)

Study Completion Date

November 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Metastases, Radiotherapy, Palliative Care

Keywords

Short Course Radiotherapy, Complicated Bone Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard treatment

Arm Type

Active Comparator

Arm Description

Patients in this group are treated with 3000 cGy in 10 daily fractions

Arm Title

short course treatment

Arm Type

Experimental

Arm Description

Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Intervention Type

Radiation

Intervention Name(s)

standard treatment

Intervention Description

3000 cGy in 10 daily fractions

Intervention Type

Radiation

Intervention Name(s)

short course treatment

Intervention Description

2000 cGy in 4 fractions administered twice a day

Primary Outcome Measure Information:

Title

Efficacy of palliation using the short course scheme compared with the standard scheme

Description

Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Acute toxicity in the two treatment groups

Description

incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria

Time Frame

3 months

Title

Late toxicity in the two treatment groups

Description

incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema

Time Frame

12 months

Title

Quality of Life (QoL) assessment in the two groups

Description

Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alessio G Morganti, MD

Phone

0512143564

Ext

+39

alessio.morganti2@unibo.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessio G Morganti, MD

Organizational Affiliation

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessio G Morganti, MD

Phone

0512143564

Ext

+39

alessio.morganti2@unibo.it

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

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