TROG 14.04 Deep Inhalation Breath Hold for reduction of cardiac toxicity in patients with left sided breast cancer undergoing radiotherapy (Heart Avoiding Radiation Therapy, HART)
Trans Tasman Radiation Oncology Group (TROG Cancer Research)Dataset description
Dataset Contains: Feasibility of Deep Inhalation Breath Hold (DIBH), Dose-volume parameters for the ipsilateral lung, left anterior descending artery, contralateral breast and oesophagus, Reproducibility of the breath-hold, Guidelines for quality assurance for the use of DIBH, Resource requirements for DIBH, Resource use: health care professional time, equipment and consumables required to plan and deliver one episode of DIBH, Imaging Data: CT, Anxiety Assessment Visual Analogue Scale (VAS): Pre and Post-treatment planning CT, Pre and Post each radiotherapy fraction, Patient Reported Experience of Breath Hold Questionnaire (DIBH participants only): Pre and Post planning CT, Pre and Post the first fraction and last week of radiotherapy treatment, Patient Reported Outcome Completion and Missing Data (CoMiDa) Checklist, Approx Time Period of data collection: 2018-2019 Radiotherapy Quality Assurance, 60 participants RTQA/Imaging Dataset: RT plan, RT delivery and Imaging documentation plus EPIs (DICOM format)Subjects
Radiation Therapy |Identifiers
Source Study
Trial acronym
TROG 14.04 HART
Trial ID
ACTRN12617000237381
Purpose
Treatment
Phase
Not Applicable
Funding
Other Collaborative groups,Australia and New Zealand Breast Cancer Trials Group
Scientific enquiries
Prof Tomas Kron
Brief Summary
The primary purpose of this trial is to evaluate whether deep inhalation breath hold (DIBH) is feasible and effective for reducing the radiation dose to the heart during radiotherapy for cancer of the left breast. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with breast cancer (left or right breast) for which radiotherapy treatment is planned following breast conserving surgery or mastectomy. Study details There will be two groups .... Read more
Key Inclusion Criteria
Females greater than or equal to 18 years Written informed consent Breast cancer with an indication for radiotherapy after breast conserving surgery or mastectomy
Key Exclusion Criteria
Significant respiratory illnesses or breathing difficulties who are unable to comply with DIBH Bilateral breast cancer
Can healthy volunteers participate?
No
Population
Sample Size 62
Min. age 18 Years
Max. age No limit
Sex Females
Condition category breast cancer
Condition code Cancer
Intervention
Intervention code Prevention , Treatment: Other
The purpose of the trial is to demonstrate the feasibility to evaluate Deep Inhalation Breath Hold (DIBH) countrywide as demonstrated in patient compliance and reproducibility of set-up. The trial is a two-arm study assessing the feasibility of DIBH during Radiotherapy treatment: the intervention group corresponds to left-sided breast cancer patients whereas the control group corresponds to right sided breast cancer patients. Left sided breast cancer patients who do not proceed to treatment with .... Read more
Comparison
Control group Active
Right sided breast cancer participants and Left sided breast cancer participants who fail DIBH to receive standard of care radiotherapy only
Outcomes
Outcome: Primary Outcome - Feasibility of DIBH Feasibility will be determined by three factors: 1. Favourable DIBH plan: The difference in the geometric relation between heart and target volume in free breathing and DIBH which will be assessed in the direct comparison of treatment plans developed for the two CT scans acquired for the trial. DIBH plan will be considered favourable if the target volume DVH parameters can be assumed to be clinically non-inferior, the lung DVH is b .... Read more
Outcome: Magnitude of the potential impact of DIBH on cardiac dose in patients undergoing radiotherapy for left-sided breast cancer Magnitude of the potential impact of DIBH will be assessed by looking at the mean dose to the heart using DIBH RT plan and the dose to the heart using free breathing plan. The software used to develop the RT plans will measure/capture the mean dose to the heart. Timepoint: When left-sided breast cancer participants have completed RT planning f .... Read more
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Anonymised Individual Patient Data (IPD) collected during the trial. The specific IPD to be shared (e.g. all data, published data, data of primary outcomes) will be as per the submitted research proposal and as assessed as appropriate by TROG.
When will data be available?
Data will be made available for request after publication of the main/final study results; no end date. Note that there may be additional circumstances preventing TROG from sharing requested data.
Available to whom?
Researchers who submit a research proposal and TROG Data Request Application, which is assessed by TROG to have an appropriate scientific value.
Available for what types of analyses?
To achieve the aims in the approved proposal.