Clinical trial NCT00793962: A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
Official title: A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
mastectomy
radiotherapy
fractionation
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2008-11-19
Enrollment: 810
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: locoregional control rate
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: shu-lian wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Ye-xiong Li, M.D.
role: STUDY_CHAIR
References:
citation: 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. Cost-effectiveness of postmastectomy hypofractionated radiation therapy vs conventional fractionated radiation therapy for high-risk breast cancer. Breast. 2021 Aug;58:72-79. doi: 10.1016/j.breast.2021.04.002. Epub 2021 Apr 19.
citation: 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. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.