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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorShanghai Proton and Heavy Ion Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

1: Patients with pathologically confirmed breast cancer

Disqualifiers

1: No pathological confirmation;

Trial design

Design model

Single group

Treatments tested in this trial

  • adjuvant hypofractionated intensity-modulated proton radiotherapy

    Radiation

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

Treatment groups

67 Participants
are divided into 1 treatment group
Group A: adjuvant hypofractionated intensity-modulated proton radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the failure rate of breast reconstruction after hypofractionated proton radiotherapy

Reoperation

Time frame
within 2 years after hypofractionated proton radiotherapy

Secondary outcomes

1

Acute and late toxicities

Treatment related toxicity assessed by CTCAE v4.03

Time frame
within 5 years after radiotherapy
2

Tumor local control rate, overall survival rate and progression free survival rate

The Ipsilateral breast and regional lymph nodes recurrence, death and progression

Time frame
within 5 years after radiotherapy

Other outcomes

Sponsors and contacts

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