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RECRUITING
NCT05692674
PHASE2

A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction

Sponsor: Shanghai Proton and Heavy Ion Center

View on ClinicalTrials.gov

Summary

The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2023-01-10

Completion Date

2028-09-01

Last Updated

2023-01-20

Healthy Volunteers

No

Conditions

Interventions

RADIATION

adjuvant hypofractionated intensity-modulated proton radiotherapy

CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;

Locations (1)

Shanghai Proton and Heavy Ion center

Shanghai, Shanghai Municipality, China