Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
NCT ID: NCT07084519
Last Updated: 2025-07-24
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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NOT_YET_RECRUITING
PHASE3
190 participants
INTERVENTIONAL
2025-08-10
2030-12-31
Brief Summary
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Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction.
Intervention:
HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HFRT group
43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
hypofractionated radiotherapy
43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
CFRT group
50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
conventional fractionated radiotherapy
50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
Interventions
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hypofractionated radiotherapy
43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
conventional fractionated radiotherapy
50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
Eligibility Criteria
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Inclusion Criteria
* Karnofsky Performance Status ≥60
* Histopathologically confirmed invasive breast adenocarcinoma
* Total mastectomy \[with or without nipple-areolar complex preservation\] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins
* pT3 or N2-3 disease; or pT1-2N1
* No distant metastasis
* Completed standard neoadjuvant/adjuvant chemotherapy cycles
* ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy
* Signed informed consent
Exclusion Criteria
* Pregnancy or lactation
* T4 stage disease
* Pre-radiotherapy local/regional/distant metastasis
* Grade ≥3 implant-related adverse events irreversible before radiotherapy
* Bilateral breast cancer requiring bilateral radiotherapy
* Concurrent/secondary malignancy with disease-free interval \<5 years \[except non-melanoma skin cancer, papillary/follicular thyroid cancer, or cervical carcinoma in situ\]
* Active collagen vascular disease, e.g., SLE, scleroderma
* Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders
18 Years
75 Years
FEMALE
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Shulian Wang
Professor of radiation oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Province, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC5419
Identifier Type: -
Identifier Source: org_study_id
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