NCT06686459

A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery

A Single-center Prospective Phase II Clinical Study With a Non-blind, Single-arm Design Combined With a Parallel External Control Group to Evaluate the Efficacy and Safety of Artificial Intelligence-assisted One-stop Radiotherapy After Breast-conserving Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 860 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Background: Breast cancer became the most prevalent cancer globally in 2020, and post-surgery radiotherapy is crucial for most patients. Traditional radiotherapy is complex and time-consuming, affecting patient experience. To streamline this, an AI-assisted All-in-one (AIO) radiotherapy approach has been developed, integrating steps like target delineation and planning to reduce wait times and enhance accuracy. Preliminary results are promising, with significant time savings and high pass rates in initial assessments. Further exploration is needed to confirm the accuracy, effectiveness, and safety of AIO radiotherapy. Primary objective: To conduct a prospective phase II clinical trial to determine the feasibility (including efficacy and safety) of AIO radiotherapy, and to provide a basis for establishing standard operating procedures. Secondary objectives: To assess the impact of AIO radiotherapy on overall survival, local regional recurrence, and distant metastasis rates. To investigate the incidence and contributing factors of cardiac damage after AIO radiotherapy.

Conditions

• Breast Cancer Invasive

Interventions

Type	Name	Description
RADIATION	ALL-in-one radiotherapy	ALL-in-one radiotherapy (breast + supraclavicular + internal mammary lymph node drainage area)
RADIATION	IMRT	IMRT (breast + supraclavicular + internal mammary lymph node drainage area)

Timeline

• Start date: 2025-04-06
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-11-13
• Last updated: 2025-07-01

Locations

1 site across 1 country: China