Actively Recruiting
Safety and Efficacy of Intensity-Modulated Proton Therapy or Intensity-Modulated Radiation Therapy for Breast Cancer: A Prospective Observational Study
Led by Ruijin Hospital · Updated on 2025-02-14
500
Participants Needed
1
Research Sites
N/A
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
Researchers are studying breast cancer patients who need radiotherapy to compare two types of radiation treatments: intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT). The goal is to evaluate and compare the side effects and effectiveness of these two therapies when used before, after, or as the main treatment for breast cancer. The study will follow patients for at least five years to observe treatment safety, cancer recurrence, survival, and quality of life. Eligible patients will receive radiotherapy targeting the whole breast, chest wall, and regional lymph nodes. Treatment plans may include a boost dose for high-risk areas, decided by the radiation oncologist. Three treatment groups include patients receiving postoperative, preoperative, or definitive radiotherapy using either IMPT or IMRT. Different radiation schedules are allowed, including hypofractionated, conventional fractionated, or ultra-hypofractionated regimens, tailored to patient needs. Participants will be monitored regularly for acute side effects within six months and for late side effects, cancer recurrence, survival, and other outcomes over five years. Assessments include tracking radiation-induced toxicities, cancer control measures, and quality of life. The study also checks tumor response after preoperative or definitive radiotherapy. This long-term follow-up aims to provide comprehensive information on the safety and impact of these radiation therapies in breast cancer care.
CONDITIONS
Brief Title
Safety and Efficacy of IMPT or IMRT for Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Karnofsky Performance Status score of 70 or higher
- Histologically confirmed breast cancer with indications for preoperative, postoperative, or definitive radiotherapy
- Testing for ER, PR, HER2, and Ki67 performed on the primary breast tumor
- Women of child-bearing potential agree to use adequate contraception starting 1 month before treatment and during the study
- Ability to understand and willingness to participate and sign informed consent
You will not qualify if you...
- Pregnant or lactating women
- Severe medical conditions that may interfere with treatment or study participation
- Active collagen vascular disease or autoimmune disorders increasing radiation toxicity risk
- Contraindications to IMPT or IMRT, such as severe claustrophobia or inability to remain still during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 6 weeks depending on the regimen
Participants receive radiotherapy using either IMPT or IMRT for breast cancer. Treatment may be preoperative, postoperative, or definitive based on medical recommendations. The radiation targets the breast and regional lymph nodes with different fractionation regimens depending on clinical factors.
15 to 28 visits (in-person) depending on the fractionation regimen
Duration - Up to 5 years
Participants are monitored for acute and late radiation-induced toxicities, cancer recurrence, survival outcomes, and quality of life for up to five years after treatment completion.
Regular follow-up visits over 5 years
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
L
Lu Cao, PhD, MD
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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