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, 100021, China
Location status: Recruiting
Recruiting
NCT Number: NCT06615466
Super-Hypofractionated Partial Breast Irradiation
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
45 year–74 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- ≥45 years old, <75 years old women
- Life expectancy >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 carcinoma, papillary carcinoma, canalicular carcinoma, medullary carcinoma; primary tumor
≤3.0cm; both pN0 (axillary dissection or sentinel lymph node biopsy)
- Low-risk DCIS: tumor ≤2.5cm, low to medium grade; axillary surgery is not required or pN0
- Single focus (with MRI diagnosis)
- Vascular tumor thrombus negative
- ER and/or PR positivity (defined as strong positivity in >1% of tumor cell nuclei)
- Negative pathological margin≥2mm
- Place metal markers on the tumor bed
- Sign the informed consent form
Exclusion criteria
- 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 neoadjuvant endocrine therapy
- Previous or simultaneous contralateral breast cancer
- History of ipsilateral chest wall radiotherapy
- Have active collagen vascular disease
Treatment and study plan
partial breast irradiation
Radiation26Gy/5.2Gy/5f
Primary outcomes
-
Incidence of acute adverse reactions
Time frame: up to 6 months
Secondary outcomes
-
Incidence of late adverse reactions
Time frame: through study completion, an average of 5 year
-
Survival
Time frame: through study completion, an average of 5 year
Local recurrence rate, regional recurrence rate, distant metastasis rate, disease-free survival rate and overall survival rate
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
Registry information
Official study title
Super-Hypofractionated Partial Breast Irradiation After Breast-Conserving Surgery for Early-Stage Low-Risk Breast Cancer: a Prospective, Single-arm Trial
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2027
- First posted
- Sep 26, 2024
- Registry last updated
- Sep 26, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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