RecruitingNot ApplicableNCT06615466

Super-Hypofractionated Partial Breast Irradiation

Super-Hypofractionated Partial Breast Irradiation After Breast-Conserving Surgery for Early-Stage Low-Risk Breast Cancer: a Prospective, Single-arm Trial


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

50 participants

Start Date

Apr 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a shorter, more intensive course of radiation (called super-hypofractionated partial breast irradiation) works as well as standard radiation after breast-conserving surgery for early-stage breast cancer. Fewer, larger doses of radiation could make treatment faster and more convenient for patients. **You may be eligible if...** - You are a woman between 45 and 75 years old - You had breast-conserving surgery (lumpectomy) and your tumor was 3 cm or smaller - Your cancer is an invasive ductal carcinoma or certain other low-to-intermediate grade types - Your lymph nodes were negative (cancer had not spread to lymph nodes) - Radiation can begin within 12 weeks of surgery (or 8 weeks after chemotherapy) **You may NOT be eligible if...** - You have had prior radiation to the chest or breast - Your tumor was larger than 3 cm or had spread to lymph nodes - You have a genetic mutation (like BRCA1/2) that increases your cancer risk - You are pregnant or have connective tissue disorders (like lupus or scleroderma) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPartial Breast Irradiation

26Gy/5.2Gy/5f


Locations(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

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NCT06615466


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