Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas (ABC)
Primary Purpose
Esophageal Cancer, Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Active Breathing Control
Sponsored by
About this trial
This is an interventional prevention trial for Esophageal Cancer focused on measuring Radiotherapy, Active Breathing Control Technique
Eligibility Criteria
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.
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Active Breathing Control
Arm Description
Planning-CT will be made of patients using the Active Breathing Control Technique (in expiration and inspiration phase)
Outcomes
Primary Outcome Measures
Mean Hart Dose (MHD)
Secondary Outcome Measures
Mean Lung Dosis (MLD)
Position of the heart in relation to the target volumes
Internal Target Volume (ITV) margin (margin for breathing movement defined as ITV - Gross Tumor Volume (GTV))
Dose Volume Histogram (DVH) parameters of the heart
V5, V10, V20, V30, V40, V50, V60
Full Information
NCT ID
NCT02497664
First Posted
June 22, 2015
Last Updated
January 13, 2017
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT02497664
Brief Title
Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas
Acronym
ABC
Official Title
Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Lung Cancer
Keywords
Radiotherapy, Active Breathing Control Technique
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Breathing Control
Arm Type
Other
Arm Description
Planning-CT will be made of patients using the Active Breathing Control Technique (in expiration and inspiration phase)
Intervention Type
Other
Intervention Name(s)
Active Breathing Control
Primary Outcome Measure Information:
Title
Mean Hart Dose (MHD)
Time Frame
At 6 weeks after start of radiation therapy
Secondary Outcome Measure Information:
Title
Mean Lung Dosis (MLD)
Time Frame
At 6 weeks after start of radiation therapy
Title
Position of the heart in relation to the target volumes
Time Frame
At 6 weeks after start of radiation therapy
Title
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
Title
Dose Volume Histogram (DVH) parameters of the heart
Description
V5, V10, V20, V30, V40, V50, V60
Time Frame
At 6 weeks after start of radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas
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