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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1: Patients with pathologically confirmed breast cancer 2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction 3: No distant metastasis 4: Had no chest and breast radiotherapy history 5: Between the ages of 18 and 80 6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy 7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women 8: The patient must sign the informed consent form for receiving radiotherapy. Exclusion Criteria: 1: No pathological confirmation； 2: Distant metastasis； 3: Had chest and breast radiotherapy history 4: Organs at risk could not achieve safe dose 5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women 6: Poor general health status, i.e. KPS<70, or ECOG>2 7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months； b) Acute bacterial or systemic fungal infection；c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization； d) Patients with immunosuppression；e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy； 8: Unable to understand the purpose of treatment or unwilling/unable to sign informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adjuvant hypofractionated intensity-modulated proton radiotherapy<br>CTV1: chest wall ± regional lymph drainage area, proton therapy. | Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy<br>* CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the failure rate of breast reconstruction after hypofractionated proton radiotherapy | Reoperation | within 2 years after hypofractionated proton radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and late toxicities | Treatment related toxicity assessed by CTCAE v4.03 | within 5 years after radiotherapy | 
| Tumor local control rate, overall survival rate and progression free survival rate | The Ipsilateral breast and regional lymph nodes recurrence, death and progression | within 5 years after radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, hypofractionated, proton radiotherapy, implantation reconstruction, postoperative adjuvant radiotherapy