Application of CT-Linac-Based "All-in-One" One-Stop Radiotherapy in Breast Cancer
Recruiting · NCT07776301 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Radiotherapy procedure
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China