A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

Conditions

Breast Cancer

Keywords

breast cancer, mastectomy, radiotherapy, fractionation

Brief summary

The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.

Detailed description

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Chen S, Sun G, Wang S, Fang H, Song Y, Jin J, Liu Y, Tang Y, Jing H, Lu N, Qi S, Chen B, Tang Y, Zhao X, Song Y, Li Y.

2021-11-01

10.1016/j.ijrobp.2021.07.108

Cost-effectiveness of postmastectomy hypofractionated radiation therapy vs conventional fractionated radiation therapy for high-risk breast cancer.

Yang J, Qi SN, Fang H, Song YW, Jin J, Liu YP, Wang WH, Yang Y, Tang Y, Ren H, Chen B, Lu NN, Tang Y, Li N, Jing H, Wang SL, Li YX.

2021-04-198 citations

10.1016/j.breast.2021.04.002

Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial.

Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX.

2019-01-30255 citations

10.1016/s1470-2045(18)30813-1

Interventions

RADIATIONhypofractionation radiotherapy

radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region

RADIATIONconventional fractionation radiotherapy

50Gy/25/f/5w

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Ipsilateral histologically confirmed invasive breast cancer * Undergone total mastectomy and axillary dissection * T3-4,or \>=4 positive axillary lymph nodes * Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation * Written,informed consent * cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy * no supraclavicular or internal mammary nodes metastases * no distant metastases * enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy. * enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.

Exclusion criteria

* Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region * Previous or concurrent malignant other than non-melanomatous skin cancer * Unable or unwilling to give informed consent * bilateral breast cancer * immediate or delayed ipsilateral breast cancer reconstruction

Design outcomes

Primary

Measure	Time frame	Description
locoregional control rate	5 years	ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse

Secondary

Measure	Time frame	Description
overall survival	5 years	any death

Countries

China

Outcome results

None listed