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Trial Title:
Super-Hypofractionated Partial Breast Irradiation
NCT ID:
NCT06615466
Condition:
Breast Cancer
Radiotherapy Side Effect
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Partial Breast Irradiation
Description:
26Gy/5.2Gy/5f
Arm group label:
Partial Breast Irradiation
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥45 years old, <75 years old women
2. Life expectancy >5 years
3. Start radiotherapy within 12 weeks after breast-conserving surgery (or within 8
weeks from the end of chemotherapy)
4. 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)
5. Low-risk DCIS: tumor ≤2.5cm, low to medium grade; axillary surgery is not required
or pN0
6. Single focus (with MRI diagnosis)
7. Vascular tumor thrombus negative
8. ER and/or PR positivity (defined as strong positivity in >1% of tumor cell nuclei)
9. Negative pathological margin≥2mm
10. Place metal markers on the tumor bed
11. Sign the informed consent form
Exclusion Criteria:
1. Multiple primary tumors
2. Invasive ductal carcinoma grade 3
3. Invasive micropapillary carcinoma
4. Lobular carcinoma in situ
5. Invasive lobular carcinoma
6. Simple nipple paget's disease
7. Oncoplastic surgery
8. Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
9. Previous or simultaneous contralateral breast cancer
10. History of ipsilateral chest wall radiotherapy
11. Have active collagen vascular disease
Gender:
Female
Minimum age:
45 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Guangyi Sun
Phone:
086-18811100731
Email:
sungy@cicams.ac.cn
Contact backup:
Last name:
Shulian Wang, MD
Start date:
April 22, 2022
Completion date:
September 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06615466
