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Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors
Standard treatment for brain metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 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 1800 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 initial symptoms after radiotherapy, assessed with Likert scale (weakness, motor disorders, cognitive impairment, personality changes, loss of balance, seizures, changes in speech, vision, hearing, memory problems, nausea or vomiting are evaluated as none-mild-moderate-severe) | 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 |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| short course treatment |
| Radiation |
1800 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 Morbility Scoring Schema
| 12 months |
| Quality of Life (QoL) assessment in the two groups | Changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients) | 12 months |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |