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

S

Shanghai Proton and Heavy Ion Center

Status and phase

Enrolling
Phase 2

Conditions

Breast Cancer

Treatments

Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05692674
SPHIC-TR-BCa2022-02

Details and patient eligibility

About

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.

Enrollment

67 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

67 participants in 1 patient group

adjuvant hypofractionated intensity-modulated proton radiotherapy
Experimental group
Description:
CTV1: chest wall ± regional lymph drainage area, proton therapy.
Treatment:
Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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