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Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard treatment | Active Comparator | Patients in this group are treated with 3000 cGy in 10 daily fractions |
|
| short course treatment | Experimental | Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard treatment | Radiation | 3000 cGy in 10 daily fractions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Late toxicity in the two treatment groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessio G Morganti, MD | Contact | 0512143564 | +39 | alessio.morganti2@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessio G Morganti, MD | Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital | Recruiting | Bologna | BO | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40563650 | Derived | 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. |
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| short course treatment |
| Radiation |
2000 cGy in 4 fractions administered twice a day |
|
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 |
| 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 |
|