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NCT Number: NCT02497664

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Breathing Control

Other

Primary outcomes

  1. Mean Hart Dose (MHD)

    Time frame: At 6 weeks after start of radiation therapy

Secondary outcomes

  1. Mean Lung Dosis (MLD)

    Time frame: At 6 weeks after start of radiation therapy

  2. Position of the heart in relation to the target volumes

    Time frame: At 6 weeks after start of radiation therapy

  3. Internal Target Volume (ITV) margin (margin for breathing movement defined as ITV - Gross Tumor Volume (GTV))

    Time frame: At 6 weeks after start of radiation therapy

  4. Dose Volume Histogram (DVH) parameters of the heart

    Time frame: At 6 weeks after start of radiation therapy

    V5, V10, V20, V30, V40, V50, V60

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: ABC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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