A Phase 2 interventional study of adjuvant hypofractionated intensity-modulated proton radiotherapy in Breast Cancer, sponsored by Shanghai Proton and Heavy Ion Center. Recruiting at 1 site in China. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by Shanghai Proton and Heavy Ion Center · Phase 2, Interventional, and Treatment
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.
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.
CTV1: chest wall ± regional lymph drainage area, proton therapy.
Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy
CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;
the failure rate of breast reconstruction after hypofractionated proton radiotherapy
Reoperation
Time frame: within 2 years after hypofractionated proton radiotherapy
Acute and late toxicities
Treatment related toxicity assessed by CTCAE v4.03
Time frame: 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
Time frame: within 5 years after radiotherapy
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Shanghai Proton and Heavy Ion Center