Status:
RECRUITING
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief 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 patien...
Detailed Description
Eligible patients after breast conserving surgery will be randomized 1:1 into hypofractionated radiotherapy (HF-RT) group or conventionally fractionated radiotherapy (CF-RT) group. Patients in HF-RT ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
4052 Patients enrolled
Trial Details
Trial ID
NCT04025164
Start Date
July 1 2018
End Date
June 30 2028
Last Update
July 18 2019
Active Locations (5)
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1
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
2
Suzhou Municipal hospital
Suzhou, Jiangsu, China, 215000
3
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China, 116044
4
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, China, 200002