SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Pelvic Cancer: an Interventional, Randomized, Multicentric Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pelvic Cancer
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
- Last Updated
- 7 years ago
Overview
Brief Summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic pelvic malignant lesions
Detailed Description
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
Investigators
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
Inclusion Criteria
- •symptomatic pelvic malignant lesions (primary solid tumors or metastases from solid tumor)
- •age \> 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
- •no changes in supportive care in the week before radiotherapy
Exclusion Criteria
- •pregnancy
- •previous irradiation of the same region
Outcomes
Primary Outcomes
efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
Time Frame: 3 months
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)
Secondary Outcomes
- acute toxicity in the two treatment groups(3 months)
- late toxicity in the two treatment groups(12 months)
- Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL(12 months)