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

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.

ClinicalTrials.gov IDNCT07776301

PhaseNA

Enrollment225

SponsorFudan University

Age18 Years

SexALL

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Conditions studied

Breast Cancer

About this study

Interventions

Other: Radiotherapy procedure — 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.

Primary outcomes

Acute adverse events (6 months)

Eligibility information

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

Study locations

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.