Actively Recruiting
Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-01-03
3142
Participants Needed
1
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The role of postoperative regional nodal irradiation (RNI) for T1-2N1 intermediate-risk breast cancer is controversial, and there is a lack of class I evidence of a survival benefit from RNI. A number of retrospective studies of breast cancer patient been undertaken to risk stratify, analyse site of recurrence and assess the role of radiotherapy. RNI is currently recommended for patients at high risk of recurrence, but prospective studies in other patients are needed to assess the role of RNI. Two randomised phase III trials have confirmed the safety and efficacy of 15-fraction hypofractionated radiotherapy, while 5-fraction super-hypofractionated radiotherapy to further shorten the course of radiotherapy is a hotspot of current research. The present study aimed to investigate whether RNI improves the outcome of intermediate-risk breast cancer patients; and to assess the efficacy and toxicity of 15-fraction hypofractionated and 5-fraction super-hypofractionated radiotherapy.
CONDITIONS
Official Title
Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 45 years old or older
- Received breast-conserving surgery or total mastectomy with axillary lymph node dissection or sentinel lymph node biopsy
- Negative surgical margins
- Tumor staging meeting specific criteria for intermediate-risk breast cancer, including lymph node involvement and risk factor scoring
- Signed informed consent
You will not qualify if you...
- Presence of distant metastases
- Metastasis to ipsilateral internal breast, supraclavicular, or subclavicular lymph nodes
- Previous radiotherapy to the chest
- Bilateral breast cancer
- Currently pregnant or breastfeeding
- Previous or concurrent other malignancy with tumor-free survival less than 5 years, except certain skin and thyroid cancers and cervical carcinoma in situ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, China, 12345
Actively Recruiting
Research Team
D
Danqiong Wang
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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