Esophageal Cancer Clinical Trial
Official title:
SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Esophageal Cancer: an Interventional, Randomized, Multicentric Study
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic esophageal malignant lesions
Status | Recruiting |
Enrollment | 98 |
Est. completion date | November 8, 2023 |
Est. primary completion date | November 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - symptomatic esophageal malignant lesions (primary solid tumors or metastases from solid tumor); - age>18 years; - ECOG performance status 0-3 - no changes in supportive care in the week before radiotherapy Exclusion Criteria: - pregnancy - previous irradiation of the same region |
Country | Name | City | State |
---|---|---|---|
Italy | Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital | Bologna | BO |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 (dysphagia, odynophagia, regurgitation, chest-back pain are evaluated as none-mild-moderate-severe) | 3 months | |
Secondary | 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 | 3 months | |
Secondary | late toxicity in the two treatment groups | incidence of treatment-related adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema | 12 months | |
Secondary | Quality of Life (QoL): EORTC questionnaire C15-PAL | changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients) | 12 months |
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