Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic abdominal malignant lesions
Standard treatment for abdomen lesions (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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
3000 cGy in 10 daily fractions
1800 cGy in 4 fractions administered twice a day
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, BO, Italy
RECRUITINGEfficacy of palliation using the short course scheme compared with the standard scheme
Reduction of initial symptoms after radiotherapy, assessed with Likert scale (bleeding, nausea or vomiting, diarrhea, malnutrition, jaundice, weight loss, bowel obstruction 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 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
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