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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Proton and Heavy Ion center
RECRUITING
Shanghai
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 67
Treatments
Experimental: adjuvant hypofractionated intensity-modulated proton radiotherapy
CTV1: chest wall ± regional lymph drainage area, proton therapy.
Sponsors
Leads: Shanghai Proton and Heavy Ion Center

This content was sourced from clinicaltrials.gov

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