Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
About this study
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
- Condition
- Breast Cancer
- Tested
- Hypofractionated Radiotherapy, Conventional fractionated Radiotherapy
- Sponsor
- Fudan University
Who can join
- Age
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 19
- Minimum age: 18 years
- Maximum age: 70 years
- Eligible sex: Female
- Study condition: Breast Cancer
- 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 15
- 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
Where
5 sites, 5 recruiting
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Suzhou Municipal hospital
Suzhou, Jiangsu, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Contact
-
Xiaoli Yu, MD, PhD
+86-13817893133 stephanieyxl@hotmail.com
-
Jurui Luo, PhD
+86-13162996951 juruiluo@hotmail.com
Potential match only. Final eligibility is determined by the study team.