RecruitingPhase 3NCT06757621

Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer

Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer: A Multicenter Prospective Randomized Phase III Trial and Cohort Study.


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

3,142 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The role of postoperative regional nodal irradiation (RNI) for T1-2N1 intermediate-risk breast cancer is controversial, and there is a lack of class I evidence of a survival benefit from RNI. A number of retrospective studies of breast cancer patient been undertaken to risk stratify, analyse site of recurrence and assess the role of radiotherapy. RNI is currently recommended for patients at high risk of recurrence, but prospective studies in other patients are needed to assess the role of RNI. Two randomised phase III trials have confirmed the safety and efficacy of 15-fraction hypofractionated radiotherapy, while 5-fraction super-hypofractionated radiotherapy to further shorten the course of radiotherapy is a hotspot of current research. The present study aimed to investigate whether RNI improves the outcome of intermediate-risk breast cancer patients; and to assess the efficacy and toxicity of 15-fraction hypofractionated and 5-fraction super-hypofractionated radiotherapy.


Eligibility

Sex: FEMALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a shorter course of radiation therapy to the lymph node area after breast cancer surgery works as well as the standard longer course for patients with intermediate-risk breast cancer. **You may be eligible if...** - You are 45 years or older - You had breast-conserving surgery or a mastectomy with lymph node evaluation - Your surgical margins are clear (negative) - You had early-stage breast cancer (tumor size T1-2) with 1 to 3 positive lymph nodes and no distant spread - Or you received chemotherapy before surgery and your cancer responded well **You may NOT be eligible if...** - You had more than 3 positive lymph nodes - Your cancer has spread to distant parts of the body - Your surgical margins were not clear 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

RADIATIONRegional Nodal Irradiation

Patients will receive chest wall / breast radiation with or without regional nodal irradiation


Locations(1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06757621


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