Actively Recruiting
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
Led by Fudan University · Updated on 2019-07-18
4052
Participants Needed
5
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery
CONDITIONS
Official Title
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 18 to 70 years
- Imaging confirmed single lesion; if multiple tumors, must be removed by single quadrantectomy
- Breast conserving surgery with negative margins
- Axillary lymph node treatment by sentinel biopsy or level I/II dissection; if positive nodes, at least 10 lymph nodes removed
- Tumor bed marked with clips and visible on treatment planning system
- Pathologically confirmed invasive breast cancer
- Pathological stage T1-3N0-3M0
- Immunohistochemical status of ER, PR, HER2, Ki67 determined after surgery
- No distant metastases
- No supraclavicular or internal mammary node metastases
- No neoadjuvant chemotherapy
- Fit for postoperative radiotherapy with no contraindications
- Karnofsky Performance Status (KPS) 80 or above
- Signed informed consent
You will not qualify if you...
- Breast cancer stage T4 or M1
- Supraclavicular or internal mammary node metastases
- Pathologically confirmed DCIS only without invasive component
- Bilateral breast cancer or history of contralateral invasive breast cancer
- Treated with neoadjuvant chemotherapy or endocrine therapy
- Multiple lesions not removable by single quadrantectomy
- Suspicious unresected microcalcifications, densities, or palpable abnormalities in either breast
- Karnofsky Performance Status (KPS) 70 or below
- Severe cardiovascular or respiratory comorbidities
- Concurrent or previous malignancies excluding certain skin cancers
- Previous radiotherapy to chest wall or regional lymph nodes
- Medical contraindications to radiotherapy such as systemic lupus erythematosus or cirrhosis
- Pregnant or lactating
- Conditions preventing radiation therapy or follow-up
- Unable or unwilling to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Not Yet Recruiting
2
Suzhou Municipal hospital
Suzhou, Jiangsu, China, 215000
Actively Recruiting
3
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China, 116044
Not Yet Recruiting
4
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, China, 200002
Actively Recruiting
5
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xiaoli Yu, MD, PhD
CONTACT
J
Jurui Luo, PhD
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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