RecruitingPhase 3NCT03829553

Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment

Hypofractionated Versus Conventional Intensity-Modulated Radiation Therapy for Breast Cancer Patients With an Indication for Regional Nodal Irradiation: A Randomized Multi-center Phase III Trial


Sponsor

Ruijin Hospital

Enrollment

801 participants

Start Date

Feb 21, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of delivering radiation therapy after breast cancer surgery — a shorter, more intense schedule (fewer but higher-dose sessions) versus the standard longer schedule — to see which is safer and more effective at treating the underarm lymph node area. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with invasive breast cancer in one breast (confirmed by biopsy) - You have had breast-conserving surgery (lumpectomy) or a full mastectomy - Cancer was found in your underarm (axillary) lymph nodes - Your surgical margins were clear (at least 2mm) - You are in generally good health and expected to live more than 5 years - You have not had prior radiation to the chest or underarm area **You may NOT be eligible if...** - Cancer has spread to distant parts of the body (metastatic disease) - You are pregnant or breastfeeding - You have cancer in both breasts at the same time - You have had previous radiation to the chest, underarm, or neck area - You have a serious connective tissue disease (such as lupus or scleroderma) - You have severe heart disease, serious arrhythmia, or severe lung disease that would prevent radiation treatment 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

RADIATIONHypofractionated radiotherapy

4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast

RADIATIONConventional radiotherapy

5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast


Locations(1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT03829553


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