Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

NCT ID: NCT03503682

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2023-11-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Bone Metastases Radiotherapy Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard treatment

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

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type RADIATION

3000 cGy in 10 daily fractions

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)

Group Type EXPERIMENTAL

short course treatment

Intervention Type RADIATION

2000 cGy in 4 fractions administered twice a day

Interventions

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standard treatment

3000 cGy in 10 daily fractions

Intervention Type RADIATION

short course treatment

2000 cGy in 4 fractions administered twice a day

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Alessio Giuseppe Morganti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessio G Morganti, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessio G Morganti, MD

Role: CONTACT

0512143564 ext. +39

Facility Contacts

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Alessio G Morganti, MD

Role: primary

0512143564 ext. +39

References

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Zamagni A, Siepe G, Gibertoni D, Donati CM, Cellini F, Fiorica F, Pezzulla D, Deodato F, Candoli F, Bisello S, Scirocco E, Manfrida S, Gabbani M, Cilla S, Macchia G, Morganti AG. Accelerated Radiotherapy for Complicated Bone Metastases: SHARON Bone Randomized Phase III Trial Shows Non-Inferiority Compared to Standard Palliative Fractionation (NCT03503682). Cancers (Basel). 2025 Jun 16;17(12):2000. doi: 10.3390/cancers17122000.

Reference Type DERIVED
PMID: 40563650 (View on PubMed)

Other Identifiers

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RT-15-06 SHARON BONE

Identifier Type: -

Identifier Source: org_study_id

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