RecruitingPhase 2NCT06464913

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

A Randomized Phase II Trial on Omission of Chest Wall Radiotherapy After Implant-Based Breast Reconstruction in Early Breast Cancer Patients


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

152 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether chest wall radiation therapy can be safely skipped in women who have had a breast implant reconstruction after mastectomy for early-stage breast cancer. The goal is to reduce side effects without compromising cancer control. **You may be eligible if...** - You have had or are planning a breast implant-based reconstruction (one or two-step procedure) - You have invasive breast cancer diagnosed at stage T1-2N1M0 (early spread to lymph nodes, no distant spread) - You are in good functional health (ECOG 0-1) - You are receiving both pre- and post-surgery treatment **You may NOT be eligible if...** - You have another active cancer - You have serious heart, lung, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONWith 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

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NCT06464913


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