Actively Recruiting
Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-02-17
840
Participants Needed
1
Research Sites
461 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
J
Jiangsu Taizhou People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.
CONDITIONS
Official Title
Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of stage I-III breast cancer (non-T4), older than 18 years
- Complete breast cancer removal including skin-sparing or nipple-sparing mastectomy
- Postoperative adjuvant radiotherapy required as per Chinese Anticancer Society guidelines
- Immediate implant-based reconstructive surgery with tissue dilator or permanent implant
You will not qualify if you...
- Undergoing autologous breast reconstruction surgery
- Clinical or pathological T4 breast cancer
- Need for radiotherapy on both breasts
- History of prior chest radiotherapy
- Pregnancy or lactation
- Participation in other drug clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
J
Jiangsu Province People's Hospital
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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