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The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation therapy in patients with symptomatic advanced thoracic cancer.
The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of advanced thoracic 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short course radiotherapy | Radiation | An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Acute 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 |
| Quality of life |
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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, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology Center, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital | Bologna | 40100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30298381 | Derived | Farina E, Macchia G, Buwenge M, Siepe G, Zamagni A, Cammelli S, Cilla S, Wondemagegnhu T, Woldemariam AA, Uddin AFMK, Sumon MA, Cellini F, Deodato F, Morganti AG. Radiotherapy in palliation of thoracic tumors: a phase I-II study (SHARON project). Clin Exp Metastasis. 2018 Dec;35(8):739-746. doi: 10.1007/s10585-018-9942-6. Epub 2018 Oct 8. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). Values range from 0 (better status) to 10 (worst status).
| 1 year |
| Pain relief | Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain). | 1 year |
| Late toxicity | 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 |