Hypofractionated Online Adaptive Radiotherapy of Breast Cancer

March 18, 2026 updated by: Peking Union Medical College Hospital

The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:

  • Can online adaptive radiotherapy improve the accuracy of dose delivery?
  • In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities and tumor control outcomes?

Participants will Receive moderate hypofractionated radiotherapy using online adaptive radiotherapy, a dose of 43.5Gy in 15 fractions or receive ultrafractionated radiotherapy using online adaptive radiotherapy, a dose of 26Gy in 5 fractions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Online Adaptive Radiotherapy (ART) is an evolution of image-guided radiotherapy that compresses the entire process of image acquisition, plan design, verification, and radiation delivery into approximately 10-30 minutes during which patients do not need to leave the treatment bed. Online ART features rapid image acquisition, automatic contouring and plan optimization supported by artificial intelligence. Body position deviation, breast soft tissue deformation, and organ movement in different treatment fractions can affect the accuracy of radiotherapy for breast cancer patients. Online adaptive radiotherapy is expected to have dosimetric advantages in terms of target coverage and organ-at-risk (OAR) dose reduction, thereby reducing treatment-related side effects while ensuring local tumor control.

Moderate hypofractionation (40-43.5Gy/15-16f/3w) has been shown to achieve equivalent local tumor control and patient survival compared to traditional fractionationated regimens (50Gy/25f/5w), and may even reduce acute and late toxicities. Currently, moderate hypofractionationated radiotherapy has been a first-line recommendation for whole breast irradiation following breast cancer surgery. In addition, the FAST-Forward trial evaluated a shorter regimen, the ultrafractionated whole breast radiotherapy (26Gy/5f/1w) and found that local tumor control and normal tissue toxicity were comparable to the moderate hypofractionationated regimen. The Royal College of Radiologists (RCR) has endorsed 5-fraction ultrafractionationated radiotherapy as a standard option for postoperative breast cancer radiation treatment in 2020.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

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 Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female, aged ≥35 years, <70 years
  • ECOG score: 0-2
  • Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
  • Pathologically confirmed primary breast cancer
  • For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
  • Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy
  • Able to cooperate and tolerate the treatment

Exclusion Criteria:

  • Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis
  • History of radiotherapy to the neck or chest
  • Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
  • History of malignant tumors

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 26Gy/5f online adaptive radiotherapy
The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy.
Radiation: Ultrafractionated Radiation Treatment
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy.
Active Comparator: 43.5Gy/15f online adaptive radiotherapy
The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy.
Radiation: Moderate hypofractionated Radiation Treatment
The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The dose coverage of target volume as assessed by planning tumor volume V100%
Time Frame: 3 months after radiotherapy
Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.
3 months after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related toxicity
Time Frame: Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy.
Toxicity is evaluated by Common Terminology Criteria for Adverse Events v5.0.
Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy.
Local recurrence rate (LRR)
Time Frame: 3, 6, 12, 24 months after radiotherapy
LRR will be deducted from the local recurrence survival defined as the interval between date of surgery and the occurrence of local relapse.
3, 6, 12, 24 months after radiotherapy

Collaborators and Investigators

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

Sponsor

Peking Union Medical College 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)

September 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF_BCoART

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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