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RECRUITING
NCT06686459
NA

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

860

Start Date

2025-04-06

Completion Date

2027-12

Last Updated

2025-07-01

Healthy Volunteers

No

Interventions

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)

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, China