Actively Recruiting
Super-Hypofractionated Partial Breast Irradiation
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-09-26
50
Participants Needed
1
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Partial breast irradiation is currently a hot topic in clinical research, but the appropriate population and appropriate irradiation The technology and dose fractionation mode are still inconclusive. Foreign studies have mostly selected patients with low risk of recurrence. Breast-conserving surgeries for early-stage breast cancer are increasing year by year in China. It is necessary to conduct prospective clinical studies to explore the Chinese population suitable for partial breast irradiation and the appropriate radiotherapy dose fractionation model. A preliminary study in our center has compared the safety and efficacy of a 2-week schedule of partial breast irradiation (40Gy/10f) and a 3-week schedule of whole-breast radiotherapy (43.5Gy/15f) in patients with early-stage low-risk breast cancer after breast-conserving surgery. , preliminary results show that the 2-week partial breast irradiation regimen is safe and effective. This study plans to continue to select low-risk breast-conserving patients, use extracorporeal intensity-modulated radiotherapy technology, refer to the radiotherapy dose fractionation model of the FAST-Forward study, and give partial breast irradiation 5.2 Gy/f/d, a total of 5 times, with a total dose of 26Gy, to further shorten the time The radiotherapy time is 1 week, and the acute and late adverse reactions of radiotherapy and the local control of the tumor are prospectively observed. Provide evidence for conducting a national multi-center phase III clinical randomized study.
CONDITIONS
Official Title
Super-Hypofractionated Partial Breast Irradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 45 to under 75 years
- Life expectancy greater than 5 years
- Start radiotherapy within 12 weeks after breast-conserving surgery or within 8 weeks from the end of chemotherapy
- Invasive ductal carcinoma grade 1-2, or mucinous, papillary, canalicular, or medullary carcinoma with primary tumor size 3.0 cm; pN0 status
- Low-risk ductal carcinoma in situ (DCIS) with tumor size 2.5 cm, low to medium grade; no axillary surgery required or pN0
- Single tumor focus confirmed by MRI
- No vascular tumor thrombus
- Estrogen receptor (ER) and/or progesterone receptor (PR) positive (strong positivity in >1% of tumor cell nuclei)
- Negative pathological margin of at least 2 mm
- Metal markers placed on the tumor bed
- Signed informed consent form
You will not qualify if you...
- Multiple primary tumors
- Invasive ductal carcinoma grade 3
- Invasive micropapillary carcinoma
- Lobular carcinoma in situ
- Invasive lobular carcinoma
- Simple nipple Paget's disease
- Oncoplastic surgery
- Neoadjuvant chemotherapy or endocrine therapy
- Previous or simultaneous contralateral breast cancer
- History of radiation therapy to the ipsilateral chest wall
- Active collagen vascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
G
Guangyi Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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