One-stop CT-Linac radiotherapy for breast cancer
Official title: Application of CT-Linac-Based "All-in-One" One-Stop Radiotherapy in All-Scenario Breast Cancer Radiotherapy: A Prospective Clinical Study
Run by Fudan University · NCT07776301 · Data updated 2026-11-12
This trial tests a fully automated, single-session radiotherapy workflow to see if it works safely for people with breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 27, 2021 |
| Main results expected | August 27, 2028 |
| Study ends | November 27, 2028 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07776301 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed breast cancer needing radiotherapy (preoperative, postoperative, or radical) and an ECOG 0-2, who can stay still for up to 30 minutes and comply with follow-up.
✕Probably not a fit
Patients unable to tolerate radical radiotherapy, who require palliative care, or who cannot comply with follow-up may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines an all-in-one, CT-Linac based radiotherapy workflow for breast cancer patients. It will collect clinical adverse events and dosimetric data to standardize the treatment protocol. Eligible participants include adults with breast cancer who need radiotherapy and can tolerate a 30-minute treatment session, with follow-up and blood sampling as required. The study is conducted at Fudan University Shanghai Cancer Center and led by Fudan University. No collaborating sites are listed.
Why it matters
Potential benefit: If successful, the approach could streamline radiotherapy delivery and improve consistency of treatment in breast cancer.
How similar studies have gone: Prior research in automated or streamlined radiotherapy workflows has shown promise in dosimetry and workflow efficiency, but this specific all-in-one CT-Linac approach is novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Xiaoli Yu, MD, PhD
- Email: xiaoliyu@fudan.edu.cn
- Phone: +86-021-64175590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.