Short Course Radiation Therapy in Palliative Treatment of Pelvic Cancer

Study Overview
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Brief Summary
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Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic pelvic malignant lesions

Detailed Description
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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

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

Conditions
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Pelvic Cancer, Radiotherapy, Palliative Care

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 fractions | Radiation: standard treatment<br>* 3000 cGy in 10 daily fractions<br>|
| Experimental: short course treatment<br>patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval) | Radiation: short course treatment<br>* 2000 cGy in 4 fractions administered twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy 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) | 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 (RTOG) | 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 | 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) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short course radiotherapy, symptomatic pelvic lesions