Actively Recruiting

Phase 3
Age: 45Years +
FEMALE
NCT06757621

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

Age: 45Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer | DecenTrialz