RecruitingNot ApplicableNCT04025164

Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery

Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial

Sponsor

Fudan University

Enrollment

4,052 participants

Start Date

Jul 1, 2018

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria15

Female
Age18-70 years
Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy
Receive breast conserving surgery with negative margins
Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed.
The tumor bed is labeled with clips and it can be drawn on the treatment planning system.
Pathologically confirmed invasive breast cancer
Pathologically stage is T1-3N0-3M0
Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery
No distant metastases
No supraclavicular or internal mammary nodes metastases
No neoadjuvant chemotherapy
Fit for postoperative radiotherapy. No contraindications to radiotherapy
KPS≥80
Signed informed consent

Exclusion Criteria15

T4 or M1 breast cancer
Supraclavicular or internal mammary nodes metastases
Pathologically confirmed DCIS only without an invasive component
Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy
Multiple lesions can not be removed by single quadrantectomy
Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast)
KPS ≤ 70
Patients with severe non-malignant comorbidity in cardiovascular or respiration system
Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
Previous radiotherapy to the chest wall or regional lymph node areas
Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
Pregnant or lactating
Conditions indicating that the patient cannot go through the radiation therapy or follow up
Unable or unwilling to sign informed consent