Short Course Radiation Therapy in Palliative Treatment of Abdominal Cancer

Study Overview
=================
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

Official Title
-----------------
SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Abdominal Cancer: an Interventional, Randomized, Multicentric Study

Conditions
-----------------
Abdomen Tumors, Radiotherapy, Palliative Care

Intervention / Treatment
-----------------
* Radiation: standard treatment
* Radiation: short course treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard treatment<br>patients in this group are treated with 3000 cGy in 10 daily fraction | Radiation: standard treatment<br>* 3000 cGy in 10 daily fractions<br>|
| Experimental: short course treatment<br>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<br>* 1800 cGy in 4 fractions administered twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 (bleeding, nausea or vomiting, diarrhea, malnutrition, jaundice, weight loss, bowel obstruction are evaluated as none-mild-moderate-severe) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | incidence of treatment-related 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Short Course Radiotherapy, Symptomatic abdomen lesions