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

February 26, 2024 updated by: University Medical Center Groningen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Lung Dosis (MLD)
Time Frame: At 6 weeks after start of radiation therapy
At 6 weeks after start of radiation therapy
Position of the heart in relation to the target volumes
Time Frame: At 6 weeks after start of radiation therapy
At 6 weeks after start of radiation therapy
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
At 6 weeks after start of radiation therapy
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
At 6 weeks after start of radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimated)

July 14, 2015

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2015-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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