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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: hypofractionation radiotherapy; Radiation: conventional fractionation radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00793962

LC2008A06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 810 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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810 participants in 2 patient groups

hypofractionation radiotherapy

Experimental group

Description:

breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region

Treatment:

Radiation: hypofractionation radiotherapy

conventional fractionation radiotherapy

Active Comparator group

Description:

breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region

Treatment:

Radiation: conventional fractionation radiotherapy