Palliative Short Course Radiotherapy for Advanced Thoracic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Palliative Short Course Accelerated Radiation Therapy for Advanced Thoracic 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 thoracic 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. | Radiation: Short course radiotherapy<br>* An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

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