Left-side breast cancer after breast-conserving surgery
Conditions
Interventions
Experimental group:Proton Hypofractionated Radiotherapy
Sponsors
Shanghai Proton and Heavy Ion Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Left-sided breast cancer confirmed by histopathology; 2. Hypofractionated proton radiotherapy in the whole breast/- regional lymphatic drainage area after breast conserving surgery; 3. Complete baseline examinations such as myocardial enzyme profile, electrocardiogram and cardiac ultrasound before radiotherapy; 4. Age between 18~80 years old; 5. Distant metastasis is ruled out by CT, MRI, bone scan, or PET/CT examination; 6.ECOG 0~2; 7. Patients must sign the informed consent form to receive radiotherapy;
Exclusion criteria
Exclusion criteria: 1. Patients with breast cancer with unconfirmed pathology, or right breast cancer; 2. With distant metastasis; 3. Received radiation therapy to the ipsilateral chest or breast; 4. The dose limit of endangering organs cannot reach the preset safe dose limit; 5. Pregnancy (confirmed by serum or urine ß-HCG test) or lactation; 6. Poor general health (KPS2); 7. Accompanied by serious diseases or factors that may affect the progress of radiotherapy, including: a) Unstable angina, congestive heart failure, myocardial infarction requiring hospitalization within the past 6 months; b) Acute bacterial or systemic fungal infections; c) Chronic obstructive pulmonary disease exacerbation or other respiratory disease requiring hospitalization; d) Patients with immunosuppression; e) drug or alcohol dependence; f) History of psychiatric illness that may preclude completion of treatment; g) With connective tissue disease, such as active scleroderma or lupus contraindications to radiation therapy; h) HIV positive (including previous antiretroviral therapy), active hepatitis C, active syphilis; i) Have other diseases or factors that may affect particle therapy; 8. Unable to understand the purpose of treatment or unwilling to sign the informed consent form for treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| metabolic markers for subclinical cardiac injury;Prevalence of subclinical cardiac damage events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life;Disease-free survival,DFS;Overall survival, OS;Distant metastasis?free survival, DMFS;Early (within 3 months) adverse reactions and late (more than 3 months) adverse reactions after radiotherapy; | — |
Countries
China
Contacts
Public ContactBao Cihang;Zhang Qing;Sun Jun
Shanghai Proton and Heavy Ion Hospital
Outcome results
None listed