Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas

Study Overview
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Brief Summary
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Neo-adjuvant chemoradiotherapy (neo-CRT) is increasingly applied in the curative treatment of esophageal cancer, with the aim to downstage the tumor, to increase the rate of radical resections, and consequently to improve the survival rates. Due to improved survival, it will become increasingly important to minimize the radiation-induced toxicity among long-term survivors. In the management of locally advanced non small cell lung cancer (NSCLC), radiotherapy is the standard treatment modality. However, the dose that can be safely applied to the tumour is limited by the risk of cardiac and pulmonary complications, which even led to decreased survival in a randomised study, when a higher tumor dose was administered [1]. Radiation induced pulmonary and cardiac toxicity are the most important late side effects after thoracic radiotherapy [2-4]. The aim of this study is to reduce the radiation dose of heart (and lungs) in order to reduce the toxicity risk. In recent years, the active breathing control (ABC) technique has been introduced in the radiotherapy for left sided breast cancer patients, to minimize the radiation dose to the heart. These patients are irradiated in the inspiration phase, in which the distance between the heart and the breast is largest, while the lungs extend. Breath hold might also be beneficial for radiotherapy of esophageal and lung tumors. For these patients the expiratory phase might theoretically be more beneficial to reduce the heart dose. However, the inspiration phase might be better for the dose to the lungs, which consequently allows cardiac dose reduction.

Official Title
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Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas

Conditions
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Lung Cancer, Esophageal Cancer

Intervention / Treatment
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* Other: Active Breathing Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven esophageal cancer (adeno-, or squamous cell carcinoma) of the mid or distal esophagus or stage III NSCLC (any histological subtype). Scheduled for external-beam photon radiotherapy with curative intention. WHO 0-2. Age >= 18 years Written informed consent. Exclusion Criteria: Serious respiratory distress Noncompliance with any of the inclusion criteria.

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active Breathing Control<br>Planning-CT will be made of patients using the Active Breathing Control Technique (in expiration and inspiration phase) | Other: Active Breathing Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Hart Dose (MHD) |  | At 6 weeks after start of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Lung Dosis (MLD) |  | At 6 weeks after start of radiation therapy | 
| Position of the heart in relation to the target volumes |  | At 6 weeks after start of radiation therapy | 
| Internal Target Volume (ITV) margin (margin for breathing movement defined as ITV - Gross Tumor Volume (GTV)) |  | At 6 weeks after start of radiation therapy | 
| Dose Volume Histogram (DVH) parameters of the heart | V5, V10, V20, V30, V40, V50, V60 | At 6 weeks after start of radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Active Breathing Control Technique