RecruitingNot ApplicableNCT06686459

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


Sponsor

Sun Yat-sen University

Enrollment

860 participants

Start Date

Apr 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using artificial intelligence (AI) to plan and deliver radiation therapy in a single streamlined session ("one-stop" radiotherapy) is safe and effective for women with breast cancer who have had breast-conserving surgery. **You may be eligible if...** - You are a woman aged 18–70 - You have newly diagnosed invasive breast cancer and had breast-conserving (lumpectomy) surgery with removal of lymph nodes - Your lymph nodes tested positive for cancer, but your surgical margins are clear - Your cancer has not spread to distant organs - Your heart function is adequate (ejection fraction ≥ 50%) - You have completed any required chemotherapy **You may NOT be eligible if...** - You have bilateral (both sides) breast cancer - You had only a sentinel lymph node biopsy without full lymph node removal - You had breast reconstruction or implants at the same time as surgery - You had a heart attack or unstable heart problems in the past 3 months - You have had prior radiation to the chest or another current cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONALL-in-one radiotherapy

ALL-in-one radiotherapy (breast + supraclavicular + internal mammary lymph node drainage area)

RADIATIONIMRT

IMRT (breast + supraclavicular + internal mammary lymph node drainage area)


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06686459


Related Trials