Actively Recruiting
Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment
Led by Ruijin Hospital · Updated on 2022-06-02
801
Participants Needed
1
Research Sites
457 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.
CONDITIONS
Official Title
Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old
- Female with unilateral invasive breast carcinoma confirmed by biopsy (pT1-3)
- Have undergone breast conservation surgery or mastectomy
- Breast reconstruction is allowed
- Histologically confirmed positive axillary lymph nodes (including positive sentinel lymph nodes without axillary dissection)
- Life expectancy greater than 5 years
- Surgical margins of at least 2mm negative
- Karnofsky Performance Status 80 or higher
- Hormone receptor and HER-2 status tests available on tumor or lymph nodes
- Able and willing to provide written informed consent
You will not qualify if you...
- Presence of positive supraclavicular lymph nodes, positive ipsilateral internal mammary lymph nodes, or residual axillary nodes eligible for boost
- Pregnant or breastfeeding
- Severe non-cancer medical conditions that prevent radiation therapy (e.g., severe heart disease, arrhythmia, or chronic lung disease)
- Diagnosis of non-breast cancer within 5 years before enrollment (except basal cell skin cancer or cervical carcinoma in situ)
- Simultaneous cancer in the opposite breast
- Previous radiation therapy to chest, axillary, or neck regions
- Active collagen vascular disease
- Evidence of distant metastasis or T4 tumor stage
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
J
Jia-Yi Chen
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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