Esophageal CancerABCNCT02497664
Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas
A study of Esophageal Cancer and Lung Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Lung Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Serious respiratory distress
- Noncompliance with any of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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].
Read more
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.
- Conditions
- Esophageal Cancer, Lung Cancer
- Being tested
- Active Breathing Control
- Keywords
- Radiotherapy, Active Breathing Control Technique
- Medical subject headings
- Esophageal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Breathing ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Active Breathing Control | Other | Planning-CT will be made of patients using the Active Breathing Control Technique (in expiration and inspiration phase) Receives: Other: Active Breathing Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hart Dose (MHD)
Measured: At 6 weeks after start of radiation therapy
Secondary outcomes (4)
Mean Lung Dosis (MLD)
Measured: At 6 weeks after start of radiation therapy
Position of the heart in relation to the target volumes
Measured: At 6 weeks after start of radiation therapy
Internal Target Volume (ITV) margin (margin for breathing movement defined as ITV - Gross Tumor Volume (GTV))
Measured: At 6 weeks after start of radiation therapy
Dose Volume Histogram (DVH) parameters of the heart
V5, V10, V20, V30, V40, V50, V60
Measured: At 6 weeks after start of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497664
- Sponsor's protocol ID
- RT2015-04
- Acronym
- ABC
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2015
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas
- ClinicalTrials.gov ID
- NCT02497664
- Acronym / sponsor ID
- ABC / RT2015-04
- Conditions
- Esophageal Cancer, Lung Cancer
- Keywords
- Radiotherapy, Active Breathing Control Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Breathing Control | Other | Other: Active Breathing ControlPlanning-CT will be made of patients using the Active Breathing Control Technique (in expiration and inspiration phase) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Serious respiratory distress
- Noncompliance with any of the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Breathing Control | Other | Active Breathing Control |
Primary outcome
Mean Hart Dose (MHD)
Time frame: At 6 weeks after start of radiation therapy
4 secondary outcomes
Mean Lung Dosis (MLD)
Time frame: 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
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
Dose Volume Histogram (DVH) parameters of the heart
Time frame: At 6 weeks after start of radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Esophageal Cancer and Lung Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Hart Dose (MHD) (time frame: At 6 weeks after start of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.