Actively Recruiting
A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.
Led by Shanghai Proton and Heavy Ion Center · Updated on 2025-05-30
780
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast cancer
- Indications for adjuvant radiotherapy after lumpectomy or mastectomy for left breast cancer
- Post lumpectomy: Pathology staged as pT1-3 N1-3, excluding N3c
- Post mastectomy: Pathology staged as pT1-3 N1-3, excluding N3c, with implant placed
- Patients who received neoadjuvant chemotherapy or endocrine/targeted therapy with postoperative stage ypT1-3 N0-3, excluding N3c
- No distant metastasis
- Age between 18 and 80 years
- ECOG performance status score 0-2
- Non-pregnant and non-lactating women
- Provided written informed consent before radiotherapy
You will not qualify if you...
- Presence of Ductal Carcinoma In Situ (DCIS)
- Tumor stage T4, N0, or N3c
- Previous radiotherapy to the same (ipsilateral) chest or breast
- Surgical margins positive or close (invasive carcinoma within 1 mm of margin)
- Bilateral breast cancer, either simultaneous or previous on the opposite side
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Proton and Heavy Ion Center
Shanghai, China
Actively Recruiting
Research Team
P
Ping Li, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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