Proton vs Photon IMRT Toxicity in Breast Cancer

Starting soon

Conditions studied: Breast Cancer

In brief

This study aims to compare the differences in acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with a focus on evaluating their impact on critical organs, including the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues. Eligible patients will be followed for at least one year to assess the incidence and severity of both acute and late toxicities, as well as differences in patient-reported outcomes (PROs), cosmetic outcomes following breast-conserving surgery, and overall quality of life.

Key facts

Study ID

NCT07537712

Run by

Ruijin Hospital

People needed

750

Starts

2026-04-01

Expected to finish

2027-12-01

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged ≥18 years.
• Pathological diagnosis of invasive breast cancer or ductal carcinoma in situ.
• Undergone breast-conserving surgery or total mastectomy, with or without stage I breast reconstruction.
• For invasive carcinoma, sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection was performed.
• Required postoperative adjuvant radiotherapy.
• Karnofsky Performance Status (KPS) score ≥ 70.
• The estimated life expectancy of greater than 5 years .
• Planned to receive photon intensity-modulated radiotherapy (IMRT) or proton IMRT, with written informed consent obtained.

You may not qualify if…

• Prior history of chest radiotherapy.
• Severe cardiopulmonary dysfunction or other conditions that contraindicate radiotherapy.
• Pregnancy or breastfeeding.
• Concurrent active malignancies.

Where it is running

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China

Full record on ClinicalTrials.gov

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