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

January 2, 2025 updated by: Shulian Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer: A Multicenter Prospective Randomized Phase III Trial and Cohort Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3142

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 12345
        • Recruiting
        • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shu-Lian Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥45 years old
  2. Receiving breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy
  3. Negative surgical margins
  4. Tumor staging： A. patients without neoadjuvant chemotherapy: pT1-2N1M0, axillary lymph node dissection with 1-3 metastatic lymph nodes, at least 1 lymph node with macroscopic metastasis, and a score of 0-2 according to the following risk factors: ≤40 years of age (1 point), tumour located in the inner quadrant (1 point), 2-3 lymph nodes positive in the axilla (1 point), presence of choroidal tumour thrombus (1 point), and restaging according to the 8th edition of the staging criteria (IB-IIA 1 point, and IIB-IIIA 2 points) B. patients without neoadjuvant chemotherapy: pT1-2N1M0, sentinel lymph node biopsy with 1-2 metastatic lymph nodes, at least 1 lymph node with macroscopic metastasis, and a score of 0-2 according to the following risk factors: ≤40 years of age (1 point), tumour located in the inner quadrant (1 point), 2-3 lymph nodes positive in the axilla (1 point), presence of choroidal tumour thrombus (1 point), and restaging according to the 8th edition of the staging criteria (IB-IIA 1 point, and IIB-IIIA 2 points) C. patients with neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0, requiring positive clinical lymph nodes with pathological confirmation, receiving ≥6 cycles of neoadjuvant chemotherapy, and ≥3 sentinel lymph nodes detected for those with simple sentinel lymph node biopsy
  5. Signed informed consent

Exclusion Criteria:

  1. Distant metastases
  2. Metastasis to ipsilateral internal breast, supraclavicular or subclavicular lymph nodes
  3. Previous radiotherapy to the chest
  4. Bilateral breast cancer
  5. Pregnancy, breastfeeding
  6. Previous or concurrent other malignancy with tumor-free survival <5 years (but excluding skin cancer with non-malignant melanoma, papillary/follicular thyroid cancer, cervical carcinoma in situ)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated Postoperative Regional Nodal Irradiation
Radiation: Regional Nodal Irradiation
Patients will receive chest wall / breast radiation with or without regional nodal irradiation
No Intervention: Without Hypofractionated Postoperative Regional Nodal Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-Free Survival Rate
Time Frame: through study completion, an average of 10 year
through study completion, an average of 10 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rate
Time Frame: through study completion, an average of 10 year
Survival
through study completion, an average of 10 year
Locoregional Recurrence Rate
Time Frame: through study completion, an average of 10 year
Survival
through study completion, an average of 10 year
Distant Metastasis Rate
Time Frame: through study completion, an average of 10 year
Survival
through study completion, an average of 10 year
Incidence of acute and late adverse reactions
Time Frame: through study completion, an average of 10 year
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.
through study completion, an average of 10 year
Quality of life Questionnaire (EORTC QLQ-C30)
Time Frame: through study completion, an average of 2 year
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
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)
Time Frame: through study completion, an average of 2 year
for the Symptom Scale/Individual Measures, higher scores indicate more severe symptoms or problems.
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2032

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4876; 24/464-4744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD often includes sensitive personal information about patients. Sharing such data could breach patient confidentiality agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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