Actively Recruiting
Safety and Efficacy of IMPT or IMRT for Breast Cancer
Led by Ruijin Hospital · Updated on 2025-02-14
500
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
S
Shandong Cancer Hospital and Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of IMPT or IMRT for Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 2 years or older
- Karnofsky Performance Status (KPS) score of 70 or higher
- Histologically confirmed breast cancer requiring preoperative, postoperative, or definitive radiotherapy
- Testing of estrogen receptor (ER), progesterone receptor (PR), HER2, and Ki67 performed on the primary tumor
- Women able to become pregnant must agree to use effective contraception starting 1 month before and during study participation
- Ability to understand and agree to participate by signing informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Severe non-cancer medical conditions that could affect treatment or study participation
- Active collagen vascular or autoimmune diseases that increase risk of radiation toxicity
- Contraindications to IMPT or IMRT, including severe claustrophobia or inability to remain still during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
G
Gang Cai, MD
CONTACT
L
Lu Cao, PhD, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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