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

Recruiting now · Phase 2

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT06464913

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

152

Starts

2024-09-01

Expected to finish

2029-09-01

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Undergoes prosthetic reconstruction (including cold knife one-step prosthetic reconstruction or two-step expander-prosthetic reconstruction.);
• Histologically confirmed invasive breast cancer patients with stage T1-2N1M0;
• ECOG score of 0-1;
• Indications for neoadjuvant therapy before surgery and adjuvant therapy after surgery.

You may not qualify if…

• Other metabolically active malignant tumors;
• Severe dysfunction of heart, lung, liver, kidney, or other vital organs;
• Uncontrolled diabetes or other endocrine diseases;
• Known allergy to radiotherapy or chemotherapy drugs;
• Pregnant or lactating women.

Where it is running

• The Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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