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Application of CT-Linac-Based "All-in-One" One-Stop Radiotherapy in Breast Cancer

Sponsor: Fudan University • ClinicalTrials.gov ID: NCT07776301

Registry updated: 2026-08-20

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Description

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.

Interventions

Radiotherapy procedure (Other)
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.

Eligibility 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

Conditions

Breast Cancer

Locations

Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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