Breast CancerPhase 2NCT06568705
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
A Phase 2 study testing Moderate hypofractionated Radiation Treatment and Ultrafractionated Radiation Treatment in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Moderate hypofractionated Radiation Treatment and Ultrafractionated Radiation Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Xiaorong Hou, MD, +86-13811963013, hxr_pumch@163.com
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Moderate hypofractionated Radiation Treatment, Ultrafractionated Radiation Treatment
- Keywords
- Online Adaptive Radiotherapy, Breast Cancer, Hypofractionated Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate hypofractionated Radiation TreatmentRadiation
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.
Ultrafractionated Radiation TreatmentRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 26Gy/5f online adaptive radiotherapy | Experimental | The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy. Receives: Radiation: Ultrafractionated Radiation Treatment |
| 43.5Gy/15f online adaptive radiotherapy | Active comparator | The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy. Receives: Radiation: Moderate hypofractionated Radiation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose coverage of target volume as assessed by planning tumor volume V100%
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.
Measured: 3 months after radiotherapy
Secondary outcomes (2)
Treatment-related toxicity
Toxicity is evaluated by Common Terminology Criteria for Adverse Events v5.0.
Measured: Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy.
Local recurrence rate (LRR)
LRR will be deducted from the local recurrence survival defined as the interval between date of surgery and the occurrence of local relapse.
Measured: 3, 6, 12, 24 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Sep 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568705
- Sponsor's protocol ID
- HF_BCoART
- Status last verified
- Feb 2026
- First submitted
- 21 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No