Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Lung Neoplasms

Esophageal Neoplasms

Respiratory Aspiration

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Esophageal Cancer

Planning-CT will be made of patients using the Active Breathing Control Technique (in expiration and inspiration phase)

Active Breathing Control

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.

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

University Medical Center Groningen

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Tomotherapy: locally advanced lung cancer (Stage III) or left breast cancer. High Frequency Percussive Ventilation will be coupled to tomotherapy treatment. The alternative procedure is free breathing.

Linear accelerator: breast cancer or pulmonary cancers (Stage I/II) requiring a stereotaxic radiotherapy.

High Frequency Percussive Ventilation will be coupled to linear accelerator. The alternative procedure is Active Breathing Control (ABC).

High Frequency Percussive Ventilation

Free breathing

Jean Bourhis, Prof

That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment in patients with tumors that are moving with respiration like breast or lung cancers. The use of a High Frequency Percussive Ventilation system leads to the cessation of respiratory motions while administering radiotherapy (RT) to tumors which allows a reduction of the amount of irradiated normal tissues and which potentially decrease radiation-induced collateral damages.

Primary objective :

Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations :

1. Tomotherapy for lung and left breast tumors. The investigators assume that the volume of irradiated healthy tissue will be much less when using HFPV as compared to free breathing during tomotherapy sessions .
2. In comparison with Active Breathing Control (ABC system). The investigators assume that the HFPV will lead to breathing motions cessation the same way as the ABC system, but will abrogate pause times when administrating the radiotherapy. This will shorten the radiotherapy sessions for lung patients treated with stereotaxis and for breast cancer patients.

Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment

Radiotherapy treatment fractions (locally advanced lung: 33 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start.

Dose distribution will be determined for both situations and patients will be treated with the most favourable one.

Lung (5 fractions) or breast (25 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start.

The time of fractions administration will be compared to theoretical times of treatment when patient is free breathing (lung 45 min for 12Gy/ breast 10 min for 2Gy).

Centre Hospitalier Universitaire Vaudois

Head of radio-oncology

Respiration Disorders

The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.

Active Breathing Coordinator (ABC)

Radiation Therapy

Pramila Rani Anne, MD

The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.

The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.

Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer

A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients

To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.

The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.

Number of participants that experienced grade three toxicity or higher as a result of treatment.

To evaluate the magnitude of change in Mean Heart Dose (MHD) and Left lung dose when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.

To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.

Sidney Kimmel Cancer Center at Thomas Jefferson University

Serious Adverse Events and Other Adverse Events were not collected/assessed.

Patients breathe through the ABC device

Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.

Active Breathing Coordinator

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Rani Anne, MD

Free breathing (heart)

ABC (heart)

Free breathing (lung)

ABC (lung)

Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues

5% reduction (heart)

20% reduction (heart)

5% reduction (lung)

20% reduction (lung)

Patients breathe through the ABC device

Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.

Proportion of Patients With Reduction in Radiation

Patients breathe through the ABC device

Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.

Radiation Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas	NCT02497664	Esophageal Canc... Lung Cancer	Active Breathin...	18 Years -	University Medical Center Groningen
Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas	NCT02497664	Esophageal Canc... Lung Cancer	Active Breathin...	18 Years -	University Medical Center Groningen
Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment	NCT02936947	Lung Cancer Breast Cancer	High Frequency ... Free breathing Active Breathin...	18 Years -	Centre Hospitalier Universitaire Vaudois
Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer	NCT00328783	Breast Cancer	Active Breathin... Radiation Thera...	18 Years -	Thomas Jefferson University

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