Abdomen Tumors, Palliative Care, Radiotherapy
Conditions
Keywords
Short Course Radiotherapy, Symptomatic abdomen lesions
Brief summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic abdominal malignant lesions
Detailed description
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
Interventions
RADIATIONshort course treatment
1800 cGy in 4 fractions administered twice a day
RADIATIONstandard treatment
3000 cGy in 10 daily fractions
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* symptomatic abdomen malignant lesions (primary solid tumor or metastases from solid tumor) * age\>18 years * ECOG performance status 0-3 * no changes in supportive care in the week before radiotherapy
Exclusion criteria
* pregnancy * previous irradiation of the same region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of palliation using the short course scheme compared with the standard scheme | 3 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute toxicity in the two treatment groups | 3 months | incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria |
| late toxicity in the two treatment groups | 12 months | incidence of treatment-related adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema |
| Quality of Life (QoL) assessment in the two groups | 12 months | 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) |
Countries
Italy
Contacts
Primary ContactAlessio G Morganti, MD
Outcome results
None listed