A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: adjuvant hypofractionated intensity-modulated proton radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Radiation adjuvant hypofractionated intensity-modulated proton radiotherapy
CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;
Primary outcome measures
- the failure rate of breast reconstruction after hypofractionated proton radiotherapy [Time frame: within 2 years after hypofractionated proton radiotherapy]
Secondary outcome measures (2)
- Acute and late toxicities [Time frame: within 5 years after radiotherapy]
- Tumor local control rate, overall survival rate and progression free survival rate [Time frame: within 5 years after radiotherapy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Proton and Heavy Ion center — Shanghai
Identifiers
NCT: NCT05692674 · SPHIC-TR-BCa2022-02