RecruitingPhase 2NCT06677879

A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.

A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.

Sponsor

Shanghai Proton and Heavy Ion Center

Enrollment

780 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are: 1. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery? 2. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of radiation therapy — proton therapy and standard photon (X-ray) radiation — for women with left-sided breast cancer who need radiation after surgery. Because the heart is on the left side, the goal is to see which approach better protects the heart and lungs. **You may be eligible if...** - You have confirmed invasive breast cancer in your left breast - You have had either a lumpectomy (breast-conserving surgery) or mastectomy - Your doctor recommends adjuvant radiation therapy - Your cancer stage is appropriate for the study (pT1-3 with certain lymph node involvement) **You may NOT be eligible if...** - You have right-sided breast cancer - You have stage IV (metastatic) breast cancer - You have certain heart conditions that affect radiation planning - You have had prior chest radiation - You are pregnant 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.

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Interventions

RADIATIONProton radiotherapy

Lumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week.

RADIATIONPhoton radiotherapy

Lumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE). Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week.

Locations(1)

Shanghai Proton and Heavy Ion Center

Shanghai, China

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NCT06677879

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