Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic pelvic malignant lesions
standard treatment for pelvic lesions (300 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
3000 cGy in 10 daily fractions
2000 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: Likert scale
reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, diarrhoea, bowel obstruction, polyuria, urinary obstruction, dysuria, lymphedema, vaginal discharge 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 (RTOG)
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/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbility Scoring Schema
Time frame: 12 months
Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL
changes in QoL after treatment assessed using EORTC questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the QoL of palliative cancer care patients)
Time frame: 12 months
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