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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Ting Zhang
zezht@zju.edu.cn
+86-571-87783521
Backup
Yucui ZHAO
yucui_zhao@163.com
+86 18818270910
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 152
Treatments
Experimental: No Chest Wall RT
This group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas.
Active_comparator: Traditional RT
This group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov