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RecruitingNCT06826885

Safety and Efficacy of IMPT or IMRT for Breast Cancer

The Safety and Efficacy of IMPT or IMRT for Breast Cancer: A Prospective Observational Study

Sponsor

Ruijin Hospital

Enrollment

500 participants

Start Date

Dec 1, 2024

Study Type

OBSERVATIONAL

Conditions

Breast CancerProton TherapyIntensity Modulated Radiation TherapyEfficacy and SafetyRadiotherapy, Adjuvant

Summary

The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of radiation therapy for breast cancer: intensity-modulated proton therapy (IMPT), which uses proton beams, and intensity-modulated radiation therapy (IMRT), which uses conventional X-rays. Both aim to destroy cancer cells while protecting healthy tissue. **You may be eligible if...** - You have been diagnosed with breast cancer requiring radiation therapy - You have had surgery (lumpectomy or mastectomy) for your breast cancer - You are in good enough health to receive radiation - Your cancer is at a stage where radiation is the standard recommendation **You may NOT be eligible if...** - Your breast cancer has spread to distant organs - You have had prior radiation to the chest area - You have serious connective tissue disease (like lupus or scleroderma) that increases radiation sensitivity - You are pregnant - You have a pacemaker or implanted device in the radiation field 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

RADIATIONPostoperative radiotherapy

Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed. A tumor bed boost will be provided to patients with high-risk factors following breast-conserving surgery, at the discretion of the radiation oncologist. The tumor bed boost regimen may consist of a sequential boost of 10-16 Gy (RBE) in 5-8 fractions, or 10-13.35 Gy (RBE) in 4-5 fractions or 10.4 Gy (RBE) in 2 fractions, or a simultaneous integrated boost of 48-49.5 Gy (RBE) in 15-16 fractions.

RADIATIONPreoperative Radiotherapy

Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed.

RADIATIONDefinitive Radiotherapy

Radiotherapy was delivered using IMPT or IMRT. The target volume encompassed the ipsilateral whole breast and regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions was preferred. Alternatively, a conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions was permitted. Dose escalation was applied in high-risk areas, resulting in a total prescribed dose exceeding 66 Gy (RBE) when calculated as equivalent doses in 2-Gy fractions (EQD2), with an α/β ratio of 4.

Locations(1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT06826885

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