Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer

September 9, 2025 updated by: Cuizhi GENG, Hebei Medical University Fourth Hospital
A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-center, open, prospective study. A total of 620 breast cancer patients meeting the exclusion criteria were included and assigned to the IORT group and the WBI group according to the patients' wishes. The IORT group received intraoperative radiotherapy with a regimen of 50-KF-x 20Gy/1f, and the WBI group received whole milk external irradiation with a regimen of 50Gy/25f. If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area. If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously. The clinical standard treatment regimen (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
620

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The fourth hospital of Hebei Medical University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The clinical stage of Tis-1N0M0 in patients undergoing breast conserving surgery for early breast cancer

Description

Inclusion Criteria:

  1. Age ≥55 years old；
  2. Cytology or histology confirmed invasive breast cancer or intraductal carcinoma in situ (DCIS) with a clinical stage of Tis-1N0M0；
  3. Patients who are willing to preserve milk and intend to undergo breast-conserving surgery；
  4. If invasive breast cancer is confirmed, the surgical margin negative ≥2mm should be met. If DCIS is confirmed, the surgical margin should be negative ≥3mm；
  5. ER≥ 30% and PR≥ 1%, HER2 negative；
  6. Voluntary participation in this study, signed informed consent, good compliance, cooperate with follow-up.

Exclusion Criteria:

  1. Simultaneous diagnosis of bilateral or multifocal breast cancer；
  2. Previous ipsilateral breast cancer and/or prior chest wall radiation therapy；
  3. There are active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest；
  4. The investigators did not consider the patient suitable for participation in any other conditions of the study.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
IORT group
The IORT group received intraoperative radiotherapy with a regimen of 50-KV-X 20Gy/1f.If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.
Procedure: radiotherapy
If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously. Clinical standard treatment plan (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.
WBI group
WBI group received whole milk external irradiation with a regimen of 50Gy/25f.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously.
Procedure: radiotherapy
If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously. Clinical standard treatment plan (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
LRFS
Time Frame: At least 5 years
There was no local recurrence survival
At least 5 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hebei Medical University Fourth Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: cuizhi GENG, archiater, Hebei Medical University Fourth Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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