An interventional study of standard treatment and short course treatment in Brain Metastases, Radiotherapy and Palliative Care, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-18.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Treatment
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
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 108 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients in this group are treated with 3000 cGy in 10 daily fractions
Radiation: standard treatment
patients in this group are treated with 1800 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Radiation: short course treatment
3000 cGy in 10 daily fractions
1800 cGy in 4 fractions administered twice a day
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)
Time frame: 3 months
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
Time frame: 3 months
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 Morbility Scoring Schema
Time frame: 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)
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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IRCCS Azienda Ospedaliero-Universitaria di Bologna