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Trial Title:
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
NCT ID:
NCT05692674
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
hypofractionated
proton radiotherapy
implantation reconstruction
postoperative adjuvant radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
adjuvant hypofractionated intensity-modulated proton radiotherapy
Description:
CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with
proton radiotherapy;
Arm group label:
adjuvant hypofractionated intensity-modulated proton radiotherapy
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Proton and Heavy Ion center
Address:
City:
Shanghai
Zip:
201321
Country:
China
Status:
Recruiting
Contact:
Last name:
Ping Li
Phone:
+86 021-38296666
Email:
ping.li@sphic.org.cn
Contact backup:
Last name:
Cihang Bao
Phone:
+86 021-38296666
Email:
cihang.Bao@sphic.org.cn
Start date:
January 10, 2023
Completion date:
September 1, 2028
Lead sponsor:
Agency:
Shanghai Proton and Heavy Ion Center
Agency class:
Other
Source:
Shanghai Proton and Heavy Ion Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05692674
