A Phase 3 interventional study of Regional Nodal Irradiation in Breast Carcinoma, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 3,142 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation: Regional Nodal Irradiation
Patients will receive chest wall / breast radiation with or without regional nodal irradiation
Disease-Free Survival Rate
Time frame: through study completion, an average of 10 year
Overall Survival Rate
Survival
Time frame: through study completion, an average of 10 year
Locoregional Recurrence Rate
Survival
Time frame: through study completion, an average of 10 year
Distant Metastasis Rate
Survival
Time frame: through study completion, an average of 10 year
Incidence of acute and late adverse reactions
CommonTerminology Criteria for Adverse Events (CTCAE) verson 5.0 and Toxicity Criteria of Radiation Therapy Oncology Group (RTOG) are uesd for assessment. Higher toxicity ratings indicate more severe reactions.
Time frame: through study completion, an average of 10 year
Quality of life Questionnaire (EORTC QLQ-C30)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) .For the Functioning Scale and the Overall Quality of Life Scale, higher scores indicate better functioning or quality of life
Time frame: through study completion, an average of 2 year
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life Questionnaire (QLQ-BR23)
for the Symptom Scale/Individual Measures, higher scores indicate more severe symptoms or problems.
Time frame: through study completion, an average of 2 year
Plan to share: No — IPD often includes sensitive personal information about patients. Sharing such data could breach patient confidentiality agreements.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences