RecruitingNot ApplicableNCT03856372

Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial


Sponsor

Fudan University

Enrollment

1,494 participants

Start Date

Sep 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a shorter (hypofractionated) radiation schedule to a longer conventional schedule after mastectomy for high-risk breast cancer, to see whether fewer sessions with higher doses work just as well with fewer long-term side effects. **You may be eligible if...** - You are a woman aged 18–75 with confirmed invasive breast cancer - You have had a mastectomy with removal of at least 10 lymph nodes - Your surgical margins are clear (cancer-free) - Your cancer meets high-risk criteria (e.g., young age, grade 3, lymph node involvement, hormone receptor-negative, or HER2-positive) - You did not receive chemotherapy before surgery (no neoadjuvant chemotherapy) **You may NOT be eligible if...** - You have had previous radiation to the chest wall or lymph node areas - You have another active cancer (other than minor skin cancers) - You have serious heart or lung disease - You have contraindications to radiation such as lupus or cirrhosis - Your cancer has spread to distant organs or to supraclavicular/internal mammary nodes 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

daily fractions, five fractions per week.

RADIATIONConventional

daily fractions, five fractions per week.


Locations(3)

Suzhou Municipal hospital

Suzhou, Jiangsu, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Huangpu Branch, Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China

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NCT03856372


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