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The study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer.
he study wants to define the safety and efficacy of a short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced solid cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-course radiotherapy | Experimental | The radiotherapy is delivered over 2 days with accelerated hypo-fractionation technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short course radiotherapy | Radiation | An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced pelvic cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of symptoms [pain] | Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain). | 1 year] |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity] | Acute toxicity after treatment is evaluated with the Common Terminology Criteria for Adverse Events (CTCAE). Values range from 1 (minimum acute toxicity) to 5 (maximum acute toxicity). | 1 year |
| Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity] |
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Inclusion Criteria:
Exclusion Criteria:
- prior radiotherapy to the same region
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| Name | Affiliation | Role |
|---|---|---|
| Alessio G. Morganti, MD | Radiation Oncology Center, S.Orsola-Malpighi Hospital, Bologna, Italy | Principal Investigator |
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| ID | Term |
|---|---|
| D010386 | Pelvic Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Late toxicity after the treatment is evaluated with the Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC). Values range from 1 (minimum late toxicity) to 5 (maximum/severe late toxicity). |
| 1 year |
| Assessment of the Quality of life (QOL) | Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). CLAS scale evaluates well-being, fatigue, and ability to perform daily activities. This method is based on a linear analogue scale. Values range from 0 (better status) to 10 (worst status). | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |