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Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
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.
Official title: A Randomized Phase II Trial on Omission of Chest Wall Radiotherapy After Implant-Based Breast Reconstruction in Early Breast Cancer Patients
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2024-09-01
Completion Date
2029-09-01
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
With or without chest wall RT
Supraclavicular and infraclavicular lymphatic drainage area radiotherapy with or without chest wall RT
Locations (1)
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China