Clinical Research Directory
Browse clinical research sites, groups, and studies.
Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
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.
Official title: Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer: A Multicenter Prospective Randomized Phase III Trial and Cohort Study.
Key Details
Gender
FEMALE
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3142
Start Date
2024-10-10
Completion Date
2032-11-01
Last Updated
2025-01-03
Healthy Volunteers
No
Conditions
Interventions
Regional Nodal Irradiation
Patients will receive chest wall / breast radiation with or without regional nodal irradiation
Locations (1)
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, China