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RECRUITING
NCT06464913
PHASE2

Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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

Interventions

RADIATION

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