Large Segmentation Radiotherapy ± Deep Inspiration Breath Hold(DIBH) for Left Breast Cancer
NCT ID: NCT06660628
Last Updated: 2024-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
348 participants
INTERVENTIONAL
2024-08-21
2034-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique
Patients with left breast cancer treated with Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique
Large Segmentation Radiotherapy
Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold
DIBH
Deep Inspiration Breath Hold
Surface guided radiation therapy
The technology uses modern 3D camera technology to help track and monitor patient movements during set-up and treatment.
laser alignment combined with free breathing treatment
Patients with left breast cancer treated with traditional laser alignment with free breathing treatment
Large Segmentation Radiotherapy
Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold
laser alignment
Laser systems for virtual simulation and patient positioning in radiotherapy
free breathing
Patients breathe calmly while radiotherapy instead of holding their breath.
Interventions
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Large Segmentation Radiotherapy
Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold
DIBH
Deep Inspiration Breath Hold
Surface guided radiation therapy
The technology uses modern 3D camera technology to help track and monitor patient movements during set-up and treatment.
laser alignment
Laser systems for virtual simulation and patient positioning in radiotherapy
free breathing
Patients breathe calmly while radiotherapy instead of holding their breath.
Eligibility Criteria
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Inclusion Criteria
2. ECOG 0, 1, 2 points
3. Pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy
4. 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.
5. No prior neoadjuvant chemotherapy or breast reconstruction.
6. No active cardiac disease, myocardial infarction, or congestive cardiac failure at baseline.
7. Patients can hold their breath for at least 30 seconds after training
8. Patients who can be followed up and agree to follow the plan.
9. Sign the consent form.
Exclusion Criteria
2. Diagnosis could not be confirmed by pathology.
3. Distant metastasis was identified.
4. The patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery.
5. Severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders
6. The patient's New York Heart Association (NYHA) cardiac classification is within categories 2-4.
7. A history of chronic lung disease, including conditions that may contribute to ductal dilatation, such as chronic obstructive pulmonary disease (COPD) and interstitial pneumonia.
8. Previous mediastinal radiotherapy.
9. 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).
10. Irradiation of the lymphatic drainage area of the internal breast is required.
18 Years
70 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-PUMCH-B-116
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
K6433
Identifier Type: -
Identifier Source: org_study_id
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