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

NCT ID: NCT05692674

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2028-09-01

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

adjuvant hypofractionated intensity-modulated proton radiotherapy

CTV1: chest wall ± regional lymph drainage area, proton therapy.

Group Type: EXPERIMENTAL

adjuvant hypofractionated intensity-modulated proton radiotherapy

Intervention Type: RADIATION

CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;

Interventions

adjuvant hypofractionated intensity-modulated proton radiotherapy

CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: lead

Responsible Party

Qing Zhang,MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Proton and Heavy Ion center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ping Li

Role: primary

ping.li@sphic.org.cn

+86 021-38296666

Cihang Bao

Role: backup

cihang.Bao@sphic.org.cn

+86 021-38296666

Other Identifiers

SPHIC-TR-BCa2022-02

Identifier Type: -

Identifier Source: org_study_id