Actively Recruiting
Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-10-15
152
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients. The main questions it aims to answer are: * Can omitting chest wall RT after prosthetic reconstruction reduce the failure rate of breast reconstruction without significantly increasing the local recurrence rate? * Does this approach ensure an improvement in the quality of life for patients without sacrificing therapeutic effectiveness? Participants will: * Be randomly assigned to one of two groups. * One group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas. * The other group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas. * Participate in follow-up assessments to monitor reconstruction failure rates and local recurrence rates. If there is a comparison group: Researchers will compare the outcomes of the two groups to evaluate the impact of chest wall RT omission on reconstruction failure and local recurrence risks.
CONDITIONS
Official Title
Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergo prosthetic breast reconstruction using cold knife one-step or two-step expander-prosthetic methods
- Have histologically confirmed invasive breast cancer at stage T1-2N1M0
- Have an ECOG performance status score of 0 or 1
- Have indications for neoadjuvant therapy before surgery and adjuvant therapy after surgery
You will not qualify if you...
- Have any other metabolically active malignant tumors
- Have severe dysfunction of heart, lung, liver, kidney, or other vital organs
- Have uncontrolled diabetes or other endocrine diseases
- Have known allergy to radiotherapy or chemotherapy drugs
- Are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Ting Zhang
CONTACT
Y
Yucui ZHAO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here