Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34

Study Overview
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Brief Summary
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RATIONALE: 3-dimensional conformal radiation therapy may lessen side effects caused by palliative radiation therapy and improve the quality of life of patients with lung cancer. PURPOSE: This clinical trial is studying how well 3-dimensional conformal radiation therapy works in reducing the side effects of palliative radiation in patients with lung cancer.

Detailed Description
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The primary purpose of this study is to demonstrate that using technically sophisticated 3-dimensional conformal radiation therapy for the palliative treatment of lung cancer patients will result in equivalent degrees of symptom relief and a reduction in the primary endpoint of oesophagitis. Single arm therapeutic clinical study. RT Treatment Regimens: 17 Gy/2 fractions or 20Gy/5 fractions or 39Gy/13 fractions Primary Endpoint: -The occurrence of Grade 3 or higher oesophagitis in the interval between start and 1-month post completion of treatment as determined by CTCAE Version 4.02 Patients will be assessed pre treatment, during treatment, 2 weeks post completion of treatment, one month post completion of treatment, three months post completion of treatment, and three monthly thereafter -All patients who complete treatment (and whose on-treatment toxicity is documented) will be evaluable. Secondary Endpoint: Quality of Life Assessment. All patients will be required to complete the EORTC QLQ-C15-PAL (Version 1) and the Lung Specific Module (LC 13) The occurrence of other AEs Safety Endpoint: -Radio-induced oesophagitis, acute and long term, using the CTCAE Version 4.02.

Official Title
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A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Radiation: 3-dimensional conformal radiation therapy
* Radiation: palliative radiation therapy
* Radiation: whole-brain radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Karnofsky Performance Status of > or equal to 40% Patients with locally advanced or metastatic small cell or non-small cell lung cancer The presence of intra-thoracic symptoms requiring palliative treatment WBI (if required) is permitted The patient's condition must permit waiting for the 3-dimensional design process to be implemented. This will be at the discretion of the Consultant Physician Patients presenting with pleural effusions - provided the pleural effusion does not prevent the reasonably accurate delineation of the target volume Intra-thoracic disease requiring palliation must be clearly evident on a diagnostic CT scan Life expectancy of at least 3 months (assessed by clinician) Provision of written informed consent in line with ICH-GCP guidelines Exclusion Criteria: -In the opinion of the Investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>A clinical trial using 3-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer | Other: questionnaire administration<br> <br> Procedure: quality-of-life assessment<br> <br> Radiation: 3-dimensional conformal radiation therapy<br> <br> Radiation: palliative radiation therapy<br> <br> Radiation: whole-brain radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02 |  | 2015 | 
| Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13) |  | 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local intra-thoracic symptoms |  | 2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, recurrent small cell lung cancer, extensive stage small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer