Actively Recruiting
Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer
Led by Fudan University · Updated on 2019-02-27
1494
Participants Needed
3
Research Sites
530 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy
CONDITIONS
Official Title
Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 18 to 75 years
- Pathologically confirmed invasive breast cancer
- Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes
- Immediate or delayed ipsilateral breast cancer reconstruction is accepted
- Negative surgical margins
- Pathologic T1-2N1 with at least one risk factor: younger than 40 years, Grade 3 tumor, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
- No distant metastases
- No metastases in supraclavicular or internal mammary nodes
- ECOG performance status 0-1
- Adjuvant systemic therapy with chemotherapy, endocrine therapy, and anti-HER2 treatment is accepted
- No neoadjuvant chemotherapy
- Fit for postoperative radiotherapy with no contraindications
- Signed informed consent
You will not qualify if you...
- Concurrent or previous malignancy except basal or squamous cell carcinoma of the skin
- Previous radiotherapy to the chest wall or regional lymph node areas
- Severe non-malignant cardiovascular or respiratory comorbidity
- Medical contraindications for radiotherapy such as systemic lupus erythematosus or cirrhosis
- Pathologic T1-2N1 without any listed risk factors
- Metastases in supraclavicular or internal mammary nodes
- Clinical or radiologic evidence of metastatic disease
- Bilateral breast cancer or confirmed contralateral invasive breast cancer
- Treated with neoadjuvant chemotherapy
- ECOG performance status 3-4
- Pregnant or lactating
- Conditions preventing radiation therapy or follow-up
- Unable or unwilling to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Suzhou Municipal hospital
Suzhou, Jiangsu, China
Not Yet Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
3
Huangpu Branch, Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
Research Team
J
Jinli Ma, MD, PhD
CONTACT
X
Xingxing Chen, MD, 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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