Breast CancerNCT07776301
Application of CT-Linac-Based "All-in-One" One-Stop Radiotherapy in Breast Cancer
A study testing Radiotherapy procedure in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to evaluate and report the clinical adverse events and dosimetric parameters in breast cancer patients undergoing an "all-in-one (AIO)" one-stop, fully automated radiotherapy workflow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2021to 27 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or pathologically confirmed breast cancer with definitive indications for radiotherapy (preoperative, postoperative, or radical)
- ECOG performance status of 0-2
- Able to remain still and supine on the treatment couch for up to 30 minutes
- Provision of signed, written informed consent
- Able to comply with daily follow-ups and blood sample collections
Who cannot join
- Palliative radiotherapy for concurrent distant metastasis
- Incomplete or ongoing chemotherapy
- Synchronous multiple primary tumors
- Current pregnancy or lactation
- Prior history of radiotherapy to the ipsilateral breast, chest wall, thorax, or regional lymph nodes
- Severe non-malignant comorbidities (e.g., cardiovascular or pulmonary diseases, systemic lupus erythematosus, scleroderma) resulting in a short life expectancy or inability to tolerate radical radiotherapy
- Inability or unlikelihood to comply with study follow-up
- Inability or unwillingness to provide written informed consent
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaofang Wang Wang, +86 18017317247, xiaofang0708@yeah.net
About this study
Official title: Application of CT-Linac-Based "All-in-One" One-Stop Radiotherapy in All-Scenario Breast Cancer Radiotherapy: A Prospective Clinical Study
This study aims to evaluate and report the clinical adverse events and dosimetric parameters in breast cancer patients undergoing an "all-in-one (AIO)" one-stop, fully automated radiotherapy workflow. By systematically tracking these clinical and physical metrics, we seek to establish a standardized clinical protocol for AIO radiotherapy in breast cancer management.
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy procedure
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy procedureOther
The workflow relies on specialized convolutional neural networks for automated segmentation and dose-prediction auto-planning. These breast cancer models were trained on 285 historical institutional cases spanning radical mastectomy and breast-conserving surgery over five years. Auto-delineated structures include the clinical target volume, regional lymph nodes (if involved), tumor bed (identified by surgical clips), heart, bilateral lungs, unaffected breast, spinal cord, esophagus, thyroid, and affected humeral head. These contours guide dose prediction to generate deliverable tangential arc plans via clinical-goal-guided automated optimization in the treatment planning system. To adapt to the on-couch treatment scenario, models were validated on retrospective data and offline routines to maximize target delineation accuracy and the first-approval rate of auto-plans.
| Study group | Role | What they receive |
|---|---|---|
| ARM1: AI-empowered AIO WBI | Other | Evaluates the feasibility, safety, and patient experiences of the AI-empowered AIO workflow in breast cancer patients undergoing whole-breast irradiation (WBI) without regional nodal involvement. Receives: Other: Radiotherapy procedure |
| ARM2: Expanded-Scenario AIO RT | Other | Evaluates the feasibility, safety, and patient experiences of the AI-empowered AIO workflow in breast cancer patients with broader radiotherapy indications, including breast/chest wall irradiation with or without regional nodal radiotherapy. Receives: Other: Radiotherapy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute adverse events
The incidence and severity of acute adverse event include radiation dermatitis, pruritus, skin pain, radiation esophagitis, and radiation pneumonitis.
Measured: 6 months
Secondary outcomes (7)
Accuracy
Auto-segmentation accuracy was assessed by comparing automatically generated contours against the final physician-approved contours
Measured: 2 months
Success rate
Record AIO workflow success rate: online planning one-pass optimization success rate.
Measured: 2 months
Quality of life (QoL)
Quality of life will be evaluated via standardized QoL scales.
Measured: 6 months
Time efficiency
The time efficiency of the workflow was automatically recorded by the system
Measured: 2 months
Full-Workflow Patient Intrafraction Motion
Evaluated based on geometric deviations between pretreatment image-guided radiotherapy (IGRT), posttreatment imaging, and the baseline simulation CT
Measured: 2 months
Correlation of Patient Metrology with Setup Error and Dosimetric Performance
Evaluation of how Body Mass Index (BMI) and weight fluctuations correlate with geometric setup errors and in vivo gamma pass rates
Measured: 2 months
Correlation of Anatomical Scale with Setup Error and Dosimetric Performance
Evaluation of how anatomical scale/breast size correlates with geometric setup errors and in vivo gamma pass rates
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start27 Aug 2021
- Primary completion27 Aug 2028 (estimated)
- Study completion27 Nov 2028 (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 Fudan UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776301
- Sponsor's protocol ID
- FDRT-BC029
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of CT-Linac-Based "All-in-One" One-Stop Radiotherapy in All-Scenario Breast Cancer Radiotherapy: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07776301
- Acronym / sponsor ID
- FDRT-BC029
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 27 Aug 2028 (estimated)
- Study completion
- 27 Nov 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate and report the clinical adverse events and dosimetric parameters in breast cancer patients undergoing an "all-in-one (AIO)" one-stop, fully automated radiotherapy workflow. By systematically tracking these clinical and physical metrics, we seek to establish a standardized clinical protocol for AIO radiotherapy in breast cancer management.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM1: AI-empowered AIO WBI | Other | Other: Radiotherapy procedureEvaluates the feasibility, safety, and patient experiences of the AI-empowered AIO workflow in breast cancer patients undergoing whole-breast irradiation (WBI) without regional nodal involvement. |
| ARM2: Expanded-Scenario AIO RT | Other | Other: Radiotherapy procedureEvaluates the feasibility, safety, and patient experiences of the AI-empowered AIO workflow in breast cancer patients with broader radiotherapy indications, including breast/chest wall irradiation with or without regional nodal radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or pathologically confirmed breast cancer with definitive indications for radiotherapy (preoperative, postoperative, or radical)
- ECOG performance status of 0-2
- Able to remain still and supine on the treatment couch for up to 30 minutes
- Provision of signed, written informed consent
- Able to comply with daily follow-ups and blood sample collections
Key exclusion criteria (8 listed)
- Palliative radiotherapy for concurrent distant metastasis
- Incomplete or ongoing chemotherapy
- Synchronous multiple primary tumors
- Current pregnancy or lactation
- Prior history of radiotherapy to the ipsilateral breast, chest wall, thorax, or regional lymph nodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy procedureThe workflow relies on specialized convolutional neural networks for automated segmentation and dose-prediction auto-planning. These breast cancer models were trained on 285 historical institutional cases spanning radical mastectomy and breast-conserving surgery over five years. Auto-delineated structures include the clinical target volume, regional lymph nodes (if involved), tumor bed (identified by surgical clips), heart, bilateral lungs, unaffected breast, spinal cord, esophagus, thyroid, and affected humeral head. These contours guide dose prediction to generate deliverable tangential arc plans via clinical-goal-guided automated optimization in the treatment planning system. To adapt to the on-couch treatment scenario, models were validated on retrospective data and offline routines to maximize target delineation accuracy and the first-approval rate of auto-plans. | Other | ARM1: AI-empowered AIO WBI, ARM2: Expanded-Scenario AIO RT |
Primary outcome
Acute adverse events
Time frame: 6 months
The incidence and severity of acute adverse event include radiation dermatitis, pruritus, skin pain, radiation esophagitis, and radiation pneumonitis.
7 secondary outcomes
Accuracy
Time frame: 2 months
Success rate
Time frame: 2 months
Quality of life (QoL)
Time frame: 6 months
Time efficiency
Time frame: 2 months
Full-Workflow Patient Intrafraction Motion
Time frame: 2 months
Correlation of Patient Metrology with Setup Error and Dosimetric Performance
Time frame: 2 months
Correlation of Anatomical Scale with Setup Error and Dosimetric Performance
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy procedure in people with Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Yu, MD, PhD (+86-021-64175590, xiaoliyu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.