Palliative Care, Pelvic Cancer, Radiotherapy
Conditions
Keywords
short course radiotherapy, symptomatic pelvic lesions
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
Interventions
RADIATIONstandard treatment
3000 cGy in 10 daily fractions
RADIATIONshort course treatment
2000 cGy in 4 fractions administered twice a day
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale | 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
| 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 (RTOG) |
| 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/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbility Scoring Schema |
| Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL | 12 months | 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) |
Countries
Italy
Contacts
Primary ContactAlessio G Morganti, MD
Outcome results
None listed