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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard treatment | Active Comparator | patients in this group are treated with 3000 cGy in 10 daily fractions |
|
| short course treatment | Experimental | patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard treatment | Radiation | 3000 cGy in 10 daily fractions |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessio G Morganti, MD | Contact | 0512143564 | +39 | alessio.morganti2@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessio G Morganti, MD | Radiation Oncology Center, Dept of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S.Orsola-Malpighi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital | Recruiting | Bologna | BO | 40138 | Italy |
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| ID | Term |
|---|---|
| D010386 | Pelvic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| short course treatment |
| Radiation |
2000 cGy in 4 fractions administered twice a day |
|
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 |
|