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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692674
• Other study ID #: SPHIC-TR-BCa2022-02
• Status: Recruiting
• Phase: Phase 2
• Start date: January 10, 2023
• Est. completion date: September 1, 2028

Study information

• Verified date: January 2023
• Source: Shanghai Proton and Heavy Ion Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 ß- 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 ß- 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• adjuvant hypofractionated intensity-modulated proton radiotherapy
CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the failure rate of breast reconstruction after hypofractionated proton radiotherapy	Reoperation	within 2 years after hypofractionated proton radiotherapy
Secondary	Acute and late toxicities	Treatment related toxicity assessed by CTCAE v4.03	within 5 years after radiotherapy
Secondary	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