Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
Recruiting · NCT04025164 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
5 locations listed.
- Guizhou Provincial People's Hospital - Guiyang, Guizhou, China
- Suzhou Municipal hospital - Suzhou, Jiangsu, China
- The Second Hospital of Dalian Medical University - Dalian, Liaoning, China
- Shanghai Huangpu District Central Hospital - Shanghai, Shanghai Municipality, China
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China