Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
Recruiting · NCT06464913 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- The Second Affiliated Hospital of Zhejiang University - Hangzhou, Zhejiang, China