Esophageal CancerBROTHERNCT06317272
BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma
A study testing DIBH using ABC technique and DIBH using VC technique in people with Esophageal Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- DIBH using ABC technique and DIBH using VC technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Feb 2021to 19 Sep 2023
- 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 of the mid or distal esophagus
- Scheduled for external-beam photon radiotherapy with curative intention.
- WHO 0-2.
- Age >= 18 years
- Written informed consent.
Who cannot join
- Serious respiratory distress
- Contra-indication for fiducial marker placement
- Noncompliance with any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BReath hOld TecHniquEs for Radiotherapy of Esophageal Carcinoma; a Feasibility Study - Part 1
The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study.
- Conditions
- Esophageal Cancer
- Being tested
- DIBH using ABC technique, DIBH using VC technique
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIBH using ABC techniqueOther
Deep breath inspiration hold (DIBH) using Active Breathing Control (ABC) technique
DIBH using VC techniqueOther
Deep breath inspiration hold (DIBH) using Voluntary Coaching (VC) technique
| Study group | Role | What they receive |
|---|---|---|
| ABC DIBH | Active comparator | Active Breathing Controlled (ABC) technique for deep breath inspiration hold (DIBH) Receives: Other: DIBH using ABC technique |
| VC DIBH | Experimental | Voluntary Coached (VC) technique for deep breath inspiration hold (DIBH) Receives: Other: DIBH using VC technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility DIBH
Breath hold maintained for >20 seconds
Measured: Week 1, 2, 3, 4, 5 during radiotherapy
Reproducibility DIBH
Diaphragm dome position within 1cm of the baseline CT Target coverage >94% of the prescribed dose (at 98% of the ITV)
Measured: Week 1, 2, 3, 4, 5 during radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start10 Feb 2021
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Why it stopped: Poor inclusion
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The participating patients will undergo weekly (during radiotherapy treatment) 2 CTs in DIBH; one using ABC and one using voluntary coaching (VC).
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C.T. Muijs, MD, PhD, Principal investigator, UMC Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317272
- Sponsor's protocol ID
- RT2016-04-BROTHER Part 1
- Acronym
- BROTHER
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BReath hOld TecHniquEs for Radiotherapy of Esophageal Carcinoma; a Feasibility Study - Part 1
- ClinicalTrials.gov ID
- NCT06317272
- Acronym / sponsor ID
- BROTHER / RT2016-04-BROTHER Part 1
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor inclusion
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 19 Mar 2024 (actual)
- 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.
The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participating patients will undergo weekly (during radiotherapy treatment) 2 CTs in DIBH; one using ABC and one using voluntary coaching (VC).
| Arm | Type | Receives |
|---|---|---|
| ABC DIBH | Active comparator | Other: DIBH using ABC techniqueActive Breathing Controlled (ABC) technique for deep breath inspiration hold (DIBH) |
| VC DIBH | Experimental | Other: DIBH using VC techniqueVoluntary Coached (VC) technique for deep breath inspiration hold (DIBH) |
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 of the mid or distal esophagus
- Scheduled for external-beam photon radiotherapy with curative intention.
- WHO 0-2.
- Age >= 18 years
- Written informed consent.
Key exclusion criteria (3 listed)
- Serious respiratory distress
- Contra-indication for fiducial marker placement
- 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 |
|---|---|---|
| DIBH using ABC techniqueDeep breath inspiration hold (DIBH) using Active Breathing Control (ABC) technique | Other | ABC DIBH |
| DIBH using VC techniqueDeep breath inspiration hold (DIBH) using Voluntary Coaching (VC) technique | Other | VC DIBH |
Primary outcome
Feasibility DIBH
Time frame: Week 1, 2, 3, 4, 5 during radiotherapy
Breath hold maintained for >20 seconds
Reproducibility DIBH
Time frame: Week 1, 2, 3, 4, 5 during radiotherapy
Diaphragm dome position within 1cm of the baseline CT Target coverage >94% of the prescribed dose (at 98% of the ITV)
Results and safety
The study was stopped early (reason given: Poor inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
C.T. Muijs, MD, PhD principal investigator
UMC Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIBH using ABC technique and DIBH using VC technique in people with Esophageal 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 3 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: stopped early, as of the sponsor's last update on 19 Mar 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 was stopped early (reason given: Poor inclusion). Results are not available in the source record.
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?
Feasibility DIBH (time frame: Week 1, 2, 3, 4, 5 during radiotherapy). The study lists 2 primary outcomes in all. 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 19 Mar 2024.