Actively Recruiting
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
Led by Shanghai Proton and Heavy Ion Center · Updated on 2023-01-20
67
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed breast cancer
- Patients who need adjuvant radiotherapy after mastectomy and implant reconstruction
- No distant metastasis
- No history of chest and breast radiotherapy
- Aged between 18 and 80 years
- ECOG general status score of 0-2 without serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease, or other complications affecting radiotherapy
- Non-pregnant or lactating women confirmed by serum or urine β-HCG test
- Signed informed consent form for receiving radiotherapy
You will not qualify if you...
- No pathological confirmation of breast cancer
- Presence of distant metastasis
- History of chest and breast radiotherapy
- Organs at risk unable to achieve safe radiation dose
- Pregnant or lactating women confirmed by serum or urine β-HCG test
- Poor general health status (KPS <70 or ECOG >2)
- Serious complications affecting radiotherapy, including unstable angina, congestive heart failure, recent myocardial infarction requiring hospitalization within 6 months, acute bacterial or systemic fungal infection, exacerbation of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization, immunosuppression, or connective tissue diseases such as active scleroderma or lupus
- Unable to understand treatment purpose or unwilling/unable to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Proton and Heavy Ion center
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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