Actively Recruiting
Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer
Led by Ruijin Hospital · Updated on 2023-08-07
1355
Participants Needed
1
Research Sites
409 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.
CONDITIONS
Official Title
Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged over 18 years
- Voluntarily agree to participate and sign informed consent
- Received radical surgery for breast cancer (breast conservation or mastectomy) with sentinel lymph node biopsy or axillary lymph node dissection
- Diagnosed with invasive breast cancer, postoperative axillary lymph node negative, pathological stage T1-3N0M0 (Stage IA, IIA, IIB)
- Have two or more high-risk factors among tumor size over 2cm, tumor site in medial or central quadrants, Ki-67 level over 14%, and positive vascular status
- Karnofsky Performance Status (KPS) score of 80 or higher
- Estimated survival time greater than 5 years
- Surgical incision completely healed with no infection
- Women of reproductive age must use contraception for at least one month before the study and throughout the study period until specified after study completion
You will not qualify if you...
- Pregnant or lactating women
- Received neoadjuvant therapy
- Serious non-cancer medical complications affecting radiotherapy
- History of malignant tumor in the past 5 years except certain in situ carcinomas
- Simultaneous contralateral breast cancer
- Previous neck, chest, or ipsilateral axillary radiotherapy
- Active collagen vascular disease
- Presence of distant metastasis confirmed by pathology or imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
D
Dan Ou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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