Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
NCT ID: NCT06568705
Last Updated: 2024-10-10
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
PHASE2
40 participants
INTERVENTIONAL
2024-09-01
2026-12-31
Brief Summary
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* Can online adaptive radiotherapy improve the accuracy of dose delivery?
* In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities and tumor control outcomes?
Participants will Receive moderate hypofractionated radiotherapy using online adaptive radiotherapy, a dose of 43.5Gy in 15 fractions or receive ultrafractionated radiotherapy using online adaptive radiotherapy, a dose of 26Gy in 5 fractions.
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Detailed Description
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Moderate hypofractionation (40-43.5Gy/15-16f/3w) has been shown to achieve equivalent local tumor control and patient survival compared to traditional fractionationated regimens (50Gy/25f/5w), and may even reduce acute and late toxicities. Currently, moderate hypofractionationated radiotherapy has been a first-line recommendation for whole breast irradiation following breast cancer surgery. In addition, the FAST-Forward trial evaluated a shorter regimen, the ultrafractionated whole breast radiotherapy (26Gy/5f/1w) and found that local tumor control and normal tissue toxicity were comparable to the moderate hypofractionationated regimen. The Royal College of Radiologists (RCR) has endorsed 5-fraction ultrafractionationated radiotherapy as a standard option for postoperative breast cancer radiation treatment in 2020.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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26Gy/5f online adaptive radiotherapy
The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy.
Ultrafractionated Radiation Treatment
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy.
43.5Gy/15f online adaptive radiotherapy
The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy.
Moderate hypofractionated Radiation Treatment
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy.
Interventions
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Moderate hypofractionated Radiation Treatment
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy.
Ultrafractionated Radiation Treatment
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy.
Eligibility Criteria
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Inclusion Criteria
* ECOG score: 0-2
* Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
* Pathologically confirmed primary breast cancer
* For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
* Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy
* Able to cooperate and tolerate the treatment
Exclusion Criteria
* History of radiotherapy to the neck or chest
* Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
* History of malignant tumors
35 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, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HF_BCoART
Identifier Type: -
Identifier Source: org_study_id
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