2D-radiotherapy in Palliation of Advanced Esophageal Cancer

Study Overview
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Brief Summary
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The study wants to define the efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal cancer.

Detailed Description
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The study wants to define the efficacy of a short course accelerated 2D-radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced esophageal cancer.

Official Title
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Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Esophageal Cancer

Conditions
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Palliative Care

Intervention / Treatment
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* Radiation: Short course radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven advanced esophageal cancer excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status age > 18 years Eastern Cooperative Oncology Group (ECOG) <3 Exclusion Criteria: prior radiotherapy to the same region

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short course radiotherapy<br>The radiotherapy is delivered over 2 days with accelerated hypo-fractionation and 2D-technique. | Radiation: Short course radiotherapy<br>* An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced esophageal cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of symptoms [odynophagia, chest-back pain, dysphagia, regurgitation] | Symptoms were graded using the IAEA scoring system. Values range from 0 (no symptom) to 4 (severe symptom). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity] | 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). | 1 year | 
| Assessment of the Performance Status | 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). | 1 year | 
| Assessment of the Overall Survival | Overall Survival is evaluated from the end of radiotherapy to the last date of follow-up. It is calculated in months. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative care, radiotherapy, pain, quality of life, esophageal cancer