Large Segmentation Radiotherapy ± Deep Inspiration Breath Hold(DIBH) for Left Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Large Segmentation Radiotherapy, DIBH, Surface guided radiation therapy, laser alignment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold for Left Sided Breast Cancer, A Real-World Study
Overview
The study is a single-center, prospective, non-randomized controlled study. The primary objective is to examine the clinical outcomes of utilizing Deep Inspiration Breath Hold (DIBH) in conjunction with hypo-fractionated radiotherapy for patients diagnosed with left-sided breast cancer with a particular focus on its potential to reduce the incidence of cardiac-related clinical and subclinical events.Participants will revieve large segmentation sadiotherapy ± DIBH for left breast cancer and be followed up to gather their clinical cardiac imformation.
Interventions
- Radiation Large Segmentation Radiotherapy
Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold - Device DIBH
Deep Inspiration Breath Hold - Device Surface guided radiation therapy
The technology uses modern 3D camera technology to help track and monitor patient movements during set-up and treatment. - Device laser alignment
Laser systems for virtual simulation and patient positioning in radiotherapy - Behavioral free breathing
Patients breathe calmly while radiotherapy instead of holding their breath.
Primary outcome measures
- Incidence of subclinical and clinical cardiac events [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
- Survival [Time frame: through study completion, an average of 1 year]
- Cosmetic results [Time frame: through study completion, an average of 1 year]
- Life quality [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 18-70 years old, female, life expectancy > 5 years
- ECOG 0, 1, 2 points
- Pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy
- The patient will receive radiation therapy to the entire breast or chest wall ± the lymphatic drainage area above and below the clavicle ± the lymphatic drainage area in the axilla.
- No prior neoadjuvant chemotherapy or breast reconstruction.
- No active cardiac disease, myocardial infarction, or congestive cardiac failure at baseline.
- Patients can hold their breath for at least 30 seconds after training
- Patients who can be followed up and agree to follow the plan.
- Sign the consent form.
Exclusion criteria
- Lesions were observed on both sides of the breast.
- Diagnosis could not be confirmed by pathology.
- Distant metastasis was identified.
- The patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery.
- Severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders
- The patient's New York Heart Association (NYHA) cardiac classification is within categories 2-4.
- A history of chronic lung disease, including conditions that may contribute to ductal dilatation, such as chronic obstructive pulmonary disease (COPD) and interstitial pneumonia.
- Previous mediastinal radiotherapy.
- Previous or concurrent second primary malignant tumor (except skin cancer that is not a malignant black pigmented tumor, papillary/follicular carcinoma of the thyroid, carcinoma in situ of the cervix, and contralateral non-invasive breast cancer).
- Irradiation of the lymphatic drainage area of the internal breast is required.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06660628 · K6433 · 2022-PUMCH-B-116