2D-radiotherapy in Palliation of Advanced Esophageal Cancer (SHARON-2D)
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|ClinicalTrials.gov Identifier: NCT03922152|
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : September 16, 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 Esophageal 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 esophageal cancer.
- Assessment of symptoms [odynophagia, chest-back pain, dysphagia, regurgitation] [ Time Frame: 1 year ]Symptoms were graded using the IAEA scoring system. Values range from 0 (no symptom) to 4 (severe symptom).
- Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity] [ Time Frame: 1 year ]Acute toxicity after treatment is evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Values range from 0 (no acute toxicity) to 4 (maximum acute toxicity).
- Assessment of the Performance Status [ Time Frame: 1 year ]Performance Status after the treatment is evaluated according with the Eastern Cooperative Oncology Group (ECOG) score. Values range from 0 (better status) to 5 (worst status).
- Assessment of the Overall Survival [ Time Frame: 1 year ]Overall Survival is evaluated from the end of radiotherapy to the last date of follow-up. It is calculated in months.
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|