2D-radiotherapy in Palliation of Advanced Solid Cancer (SHARON-2D)
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|ClinicalTrials.gov Identifier: NCT03922152|
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Palliative Care||Radiation: Short course radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Solid Cancer|
|Actual Study Start Date :||January 1, 2009|
|Actual Primary Completion Date :||January 1, 2019|
|Actual Study Completion Date :||January 1, 2019|
Experimental: Short course radiotherapy
The radiotherapy is delivered over 2 days with accelerated hypo-fractionation and 2D-technique.
Radiation: Short course radiotherapy
An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced solid cancer.
- Assessment of symptoms [pain] [ Time Frame: 1 year ]Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).
- Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity] [ Time Frame: 1 year ]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).
- Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity] [ Time Frame: 1 year ]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).
- Assessment of the Quality of life (QOL) [ Time Frame: 1 year ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922152
|Principal Investigator:||Alessio G. Morganti, MD||Radiation Oncology Center, DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy|